Shanghai JPY ION-Tech Co., Ltd.
Registered establishment in Shanghai, China. 70 device types.
Shanghai JPY ION-Tech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Arthroscope, Sheet, Burn and 68 other device types. Its earliest product listing with the FDA dates from 2004.
Registration
| Registered name | SHANGHAI JPY ION-TECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004748528 |
| FEI number | 3004748528 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 上海金鹏源辐照技术有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | NO. 1168, HUIJIN ROAD |
| Postal code | 201707 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class 2 | Trauma Internal Fixation Systems | 2026 | 17 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Class 2 | Trauma Internal Fixation Systems, Distal Volar Radius Plating Systems | 2026 | 6 |
| Appliance, Fixation, Spinal Interlaminal | Class 2 | Merlin Spine System, Synapse system, Expedium Spine System, VIPER and VIPER 2 systems, Expedium Spine System, Expedium Verse Spine System, Expedium Spine System, Viper System, Viper 2 System | 2024 | 11 |
| Appliance, Fixation, Spinal Intervertebral Body | Class 2 | Merlin Spine System, Expedium Spine System, VIPER and VIPER 2 systems, Expedium Spine System, Expedium Verse Spine System, Expedium Spine System, Viper System, Viper 2 System | 2024 | 14 |
| Arthroscope | Class 2 | 3-in-1 Shaver, 4.2mm, Curved Standard Shaver, 3.4mm, Standard Shaver, 3.4mm, Veriflow, Standard Burr, 5mm, 3-in-1 Shaver, 5mm and 5 more | 2023 | 21 |
| Cap, Device Disinfectant | Class 2 | Catheter Connections’ Dualcap, EFFECTIV-CAP for Needleless Valve, Catheter Connections’ Dualcap Solo, Catheter Connections’ Dualcap DUO | 2013 | 2 |
| Cement Obturator | Class 2 | Uhmwpe Components-Change IN Packaging, Cemented Cups | 2013 | 3 |
| Container, Sharps | Class 2 | Medline Needle Counter | 2013 | 18 |
| Dressing, Wound, Drug | Class U | Allevyn Ag Adhesive, Allevyn Ag Dressings | 2013 | 48 |
| Dressing, Wound, Occlusive | Class 1 | Allevyn Tracheostomy, ALLEVYN Non Adhesive | 2014 | 183 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | 3-in-1 Shaver, 4.2mm, Curved Standard Shaver, 3.4mm, Standard Shaver, 3.4mm, Veriflow, Standard Burr, 5mm, 3-in-1 Shaver, 5mm and 5 more | 2023 | 65 |
| Fibrin Sealant Preparation Device | Class 2 | VISTASEAL Dual Applicator | 2019 | 2 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze/Sponge,nonresorbable FOR External USE, Supra-Form conforming bandage, Sof-Form conforming bandage | 2013 | 266 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class 2 | G7 Acetabular System Item # 010001040, G7 Acetabular System Item # 010001033, G7 Acetabular System Item # 010001032, G7 Acetabular System Item # 010001031, G7 Acetabular System Item # 010001035, G7 PPS LTD ACET SHELL 42A Item # 010000658 and 105 more | 2022 | 8 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class 2 | G7 Acetabular System Item # 010001040, G7 Acetabular System Item # 010001033, G7 Acetabular System Item # 010001032, G7 Acetabular System Item # 010001031, G7 Acetabular System Item # 010001035, G7 PPS LTD ACET SHELL 42A Item # 010000658 and 36 more | 2022 | 5 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Class 2 | G7 Acetabular System Item # 010001040, G7 Acetabular System Item # 010001033, G7 Acetabular System Item # 010001032, G7 Acetabular System Item # 010001031, G7 Acetabular System Item # 010001035, G7 PPS LTD ACET SHELL 42A Item # 010000658 and 36 more | 2022 | 5 |
| Lubricant, Patient | Class 1 | Dynacor Lubrication GEL, Lubricating Jelly, Medline E-Z Lubricating Jelly Foil Pack 5G, Medline E-Z Lubricating Jelly Foil Pack 2.7G | 2013 | 33 |
| Needle, Aspiration And Injection, Disposable | Class 1 | Disposable General AND Plastic SUR, Gery | 2004 | 37 |
| Needle, Hypodermic, Single Lumen | Class 2 | Medline Needle Counter, Hypodermic Single Lumen Needle, Pen Needle | 2013 | 71 |
| Orthosis, Spinal Pedicle Fixation | Class 2 | Merlin Spine System, Synapse system, Expedium Spine System, VIPER and VIPER 2 systems, Expedium Spine System, Viper System, Viper 2 System | 2024 | 13 |
| Orthosis, Spondylolisthesis Spinal Fixation | Class 2 | Merlin Spine System, Synapse system, Expedium Spine System, VIPER and VIPER 2 systems, Expedium Spine System, Viper System, Viper 2 System | 2024 | 13 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class 2 | Expedium Spine System, VIPER and VIPER 2 systems, Expedium Spine System, Viper System, Viper 2 System | 2024 | 7 |
| Pin, Fixation, Smooth | Class 2 | Trauma Internal Fixation Systems | 2026 | 12 |
| Pin, Fixation, Threaded | Class 2 | Trauma Internal Fixation Systems | 2026 | 9 |
| Plate, Fixation, Bone | Class 2 | 2.5MM Inline Fusion Plate, Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467, Plate, Fixation, Bone, Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model 131218704-708; 851318704-708, 131218204, Trauma Internal Fixation Systems, Anatomic Locking Plating System and 3 more | 2026 | 22 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | Class 2 | Tprlc 133 T1 PPS HO 15X150MM, Tprlc 133 FP TYPE1 PPS SO 8, Tprlc 133 TYPE1 PPS SO 9X137MM, Tprlc 133 T1 PPS HO 14X148MM, Tprlc 133 FP TYPE1 PPS HO 14, Tprlc 133 FP TYPE1 PPS HO 16 and 64 more | 2022 | 7 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Class 2 | Uhmwpe Components-Change IN Packaging, Cemented Cups | 2013 | 3 |
| Prosthesis, Elbow, Semi-Constrained, Cemented | Class 2 | Uhmwpe Components-Change IN Packaging, Cemented Cups | 2013 | 3 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class 2 | Tprlc 133 T1 PPS HO 15X150MM, Tprlc 133 FP TYPE1 PPS SO 8, Tprlc 133 TYPE1 PPS SO 9X137MM, Tprlc 133 T1 PPS HO 14X148MM, Tprlc 133 FP TYPE1 PPS HO 14, Tprlc 133 FP TYPE1 PPS HO 16 and 175 more | 2022 | 10 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | Class 2 | G7 Acetabular System Item # 010001040, G7 Acetabular System Item # 010001033, G7 Acetabular System Item # 010001032, G7 Acetabular System Item # 010001031, G7 Acetabular System Item # 010001035, G7 PPS LTD ACET SHELL 42A Item # 010000658 and 36 more | 2022 | 5 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | Class 2 | Pinn Sector W/Gription 66MM, Pinn Sector W/Gription 54MM, Pinn Multihole W/Gription 70MM, Pinn Sector W/Gription 60MM, Pinn Bantam W/Gription 40MM, Pinn Bantam W/Gription 44MM and 204 more | 2013 | 10 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Class 2 | Pinn Sector W/Gription 66MM, Pinn Sector W/Gription 54MM, Pinn Multihole W/Gription 70MM, Pinn Sector W/Gription 60MM, Pinn Bantam W/Gription 40MM, Pinn Bantam W/Gription 44MM and 37 more | 2013 | 5 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class 2 | Pinn Sector W/Gription 66MM, Pinn Sector W/Gription 54MM, Pinn Multihole W/Gription 70MM, Pinn Sector W/Gription 60MM, Pinn Bantam W/Gription 40MM, Pinn Bantam W/Gription 44MM and 208 more | 2013 | 14 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | Class 3 | Tprlc 133 FP TYPE1 PPS HO 18, Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 11MM STD FEMORAL, Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO HIP FX LAT FEMORAL 9MM, Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO HIP FX LAT FEMORAL 13MM, Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 7MM STD FEMORAL, Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 17MM STD FEMORAL and 43 more | 2022 | 4 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Class 3 | Tprlc 133 FP TYPE1 PPS HO 18, Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 11MM STD FEMORAL, Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO HIP FX LAT FEMORAL 9MM, Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO HIP FX LAT FEMORAL 13MM, Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 7MM STD FEMORAL, Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) / ECHO FX 17MM STD FEMORAL and 43 more | 2022 | 4 |
| Prosthesis, Hip, Semi-Constrained, Composite/Metal | Class 2 | 2019 | 3 | |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Class 3 | Ceramax Ceramic HIP System, Pinnacle Sector II CUP 56MM, Pinnacle 100 Acet CUP 54MM, Pinnacle Sector II CUP 52MM, Pinnacle 100 Acet CUP 66MM, Pinnacle Sector II CUP 58MM and 15 more | 2024 | 2 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | Pinn Sector W/Gription 66MM, Pinn Sector W/Gription 54MM, Pinn Multihole W/Gription 70MM, Pinn Sector W/Gription 60MM, Pinn Bantam W/Gription 40MM, Pinn Bantam W/Gription 44MM and 222 more | 2013 | 15 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class 2 | Pinn Sector W/Gription 66MM, Pinn Sector W/Gription 54MM, Pinn Multihole W/Gription 70MM, Pinn Sector W/Gription 60MM, Pinn Bantam W/Gription 40MM, Pinn Bantam W/Gription 44MM and 236 more | 2013 | 13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class 2 | Pinn Sector W/Gription 66MM, Pinn Sector W/Gription 54MM, Pinn Multihole W/Gription 70MM, Pinn Sector W/Gription 60MM, Pinn Bantam W/Gription 40MM, Pinn Bantam W/Gription 44MM and 279 more | 2013 | 14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class 2 | Pinn Sector W/Gription 66MM, Pinn Sector W/Gription 54MM, Pinn Multihole W/Gription 70MM, Pinn Sector W/Gription 60MM, Pinn Bantam W/Gription 40MM, Pinn Bantam W/Gription 44MM and 54 more | 2013 | 9 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class 2 | Pinn Sector W/Gription 66MM, Pinn Sector W/Gription 54MM, Pinn Multihole W/Gription 70MM, Pinn Sector W/Gription 60MM, Pinn Bantam W/Gription 40MM, Pinn Bantam W/Gription 44MM and 204 more | 2018 | 14 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class 2 | Nexgen Lcck Femoral, Size F-LT, Nexgen Lcck Femoral, Size E-LT, Nexgen Lcck Femoral, Size D-LT, Nexgen Lcck Femoral, Size C-LT, Nexgen Lcck Femoral, Size G-RT, Nexgen Lcck Femoral, Size G-LT and 4 more | 2019 | 7 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | Vanguard CR Ilok FEM-LT 60, VAN PS Open Intl FEM-LT 75, Vngd PS Open Intl FEM-RT 57.5, VAN PS Open Intl FEM-LT 80, Vngd PS Open Intl FEM RT 55, Vngd CR Intlk Femoral 55MM RT and 36 more | 2013 | 10 |
| Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing | Class 3 | Oxford PKS Cemented tibia, Alpha, Standard – LM Size AA, Oxford PKS Cemented tibia, Alpha, Standard – LM Size A, Oxford PKS Cemented tibia, Alpha, Standard – RM Size E, Oxford PKS Cemented tibia, Alpha, Standard – LM Size F, Oxford PKS Cemented tibia, Alpha, Standard – RM Size B, Oxford PKS Cemented tibia, Alpha, Standard – RM Size AA and 13 more | 2022 | 3 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | Nexgen Lcck Femoral, Size F-LT, Nexgen Lcck Femoral, Size E-LT, Nexgen Lcck Femoral, Size D-LT, Nexgen Lcck Femoral, Size C-LT, Nexgen Lcck Femoral, Size G-RT, Nexgen Lcck Femoral, Size G-LT and 4 more | 2019 | 7 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | Class 2 | Vanguard CR Ilok FEM-LT 60, VAN PS Open Intl FEM-LT 75, Vngd PS Open Intl FEM-RT 57.5, VAN PS Open Intl FEM-LT 80, Vngd PS Open Intl FEM RT 55, Vngd CR Intlk Femoral 55MM RT and 54 more | 2018 | 5 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class 2 | Vanguard CR Ilok FEM-LT 60, VAN PS Open Intl FEM-LT 75, Vngd PS Open Intl FEM-RT 57.5, VAN PS Open Intl FEM-LT 80, Vngd PS Open Intl FEM RT 55, Vngd CR Intlk Femoral 55MM RT and 46 more | 2018 | 12 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class 2 | Vanguard CR Ilok FEM-LT 60, VAN PS Open Intl FEM-LT 75, Vngd PS Open Intl FEM-RT 57.5, VAN PS Open Intl FEM-LT 80, Vngd PS Open Intl FEM RT 55, Vngd CR Intlk Femoral 55MM RT and 38 more | 2019 | 8 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | Vanguard CR Ilok FEM-LT 60, VAN PS Open Intl FEM-LT 75, Vngd PS Open Intl FEM-RT 57.5, VAN PS Open Intl FEM-LT 80, Vngd PS Open Intl FEM RT 55, Vngd CR Intlk Femoral 55MM RT and 89 more | 2013 | 21 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | Class 3 | Attune Dome Patella, ATTUNE MEDIAL DOME PAT 38MM, Attune Dome Patella, ATTUNE MEDIAL DOME PAT 32MM, Attune Dome Patella, ATTUNE MEDIAL DOME PAT 35MM, LCS(R) Total Knee System, Attune Dome Patella, ATTUNE MEDIAL DOME PAT 29MM, Attune Dome Patella, ATTUNE MEDIAL DOME PAT 41MM | 2019 | 4 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class 2 | GLOBAL UNITE™ Platform Shoulder System, Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented, ECC Head, HUM Head, CTA Head, Global Advantage extended humeral head and 20 more | 2013 | 8 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class 2 | Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented, ECC Head, HUM Head, Versa-Dial 46X18X53 HUM Head, Versa-Dial 54X27X55 HUM Head, Versa-Dial 42X18X46 HUM Head and 14 more | 2013 | 6 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class 2 | 25MM Versa-Dial Taper Adaptor, Comp Rvrs Shldr Glnsp +6 41MM, Comp Rvsr Shldr Glnsp +3 41MM, Comp Rvrs Shldr Glnsp STD 41MM, Comp Rvrs Shldr Glnsp +6 36MM, Comp Rvsr Shldr Glnsp +3 36MM and 27 more | 2013 | 9 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class 2 | Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented, Versa-Dial 46X18X53 HUM Head, Versa-Dial 54X27X55 HUM Head, Versa-Dial 42X18X46 HUM Head, Versa-Dial 46X21X50 HUM Head, Versa-Dial 42X24X42 HUM Head and 12 more | 2022 | 5 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class 2 | Global Icon | 2026 | 2 |
| Pump, Infusion, Ophthalmic | Class 2 | OMNI Surgical System – sterile, single-use device, OMNI PLUS Surgical System – sterile, single-use device, OMNI Ultra Surgical System, OMNI Edge Surgical System | 2023 | 2 |
| Resin, Root Canal Filling | Class 2 | Pinnacle Gription | 2026 | 4 |
| Rod, Fixation, Intramedullary And Accessories | Class 2 | Trauma Internal Fixation Systems, Affixus Tibial and Antegrade Femoral Nailing System | 2024 | 17 |
| Screw, Fixation, Bone | Class 2 | Pinn Sector W/Gription 66MM, Pinn Sector W/Gription 54MM, Pinn Multihole W/Gription 70MM, Pinn Sector W/Gription 60MM, Pinn Bantam W/Gription 40MM, Pinn Bantam W/Gription 44MM and 39 more | 2024 | 31 |
| Sheet, Burn | Class 1 | Dukal Brand Item No:7305, Gam Brand Item No:650-3001-0100 | 2013 | 20 |
| Shoulder Prosthesis, Reverse Configuration | Class 2 | 25MM Versa-Dial Taper Adaptor, Comp Rvrs Shldr Glnsp +6 41MM, Comp Rvsr Shldr Glnsp +3 41MM, Comp Rvrs Shldr Glnsp STD 41MM, Comp Rvrs Shldr Glnsp +6 36MM, Comp Rvsr Shldr Glnsp +3 36MM and 6 more | 2022 | 9 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class 2 | babyLance Heel Incision Device, SurgiLance Safety Lancet, Medline Lancets, 21G & 28G safety, 30G general purpose, Acti-Lance baby | 2013 | 36 |
| Thoracolumbosacral Pedicle Screw System | Class 2 | Merlin Spine System, Expedium Spine System, VIPER and VIPER 2 systems, Expedium Spine System, Expedium Verse Spine System, Expedium Spine System, Viper System, Viper 2 System | 2024 | 15 |
| Trabeculotome | Class 1 | Sion Surgical Instrument – sterile, single-use device, OMNI Surgical System – sterile, single-use device, OMNI PLUS Surgical System – sterile, single-use device, OMNI Ultra Surgical System, OMNI Edge Surgical System | 2023 | 3 |
| Transducer, Pressure, Catheter Tip | Class 2 | transducer, pressure, catheter tip | 2020 | 4 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Class 2 | transducer, pressure, catheter tip | 2020 | 11 |
| Washer, Bolt Nut | Class 2 | Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model 131218704-708; 851318704-708, 131218204, Trauma Internal Fixation Systems, Anatomic Locking Plating System | 2026 | 9 |
| Wire, Guide, Catheter | Class 2 | transducer, pressure, catheter tip | 2020 | 10 |
| Wire, Surgical | Class 2 | Pinn Sector W/Gription 66MM, Pinn Sector W/Gription 54MM, Pinn Multihole W/Gription 70MM, Pinn Sector W/Gription 60MM, Pinn Bantam W/Gription 40MM, Pinn Bantam W/Gription 44MM and 34 more | 2025 | 2 |
Clearances
No clearance names Shanghai JPY ION-Tech Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K112110 | 2012-04-10 | KMJ | Traditional | Jianerkang Medical Dressing Company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Main products | Gamma irradiation sterilization services, medical device sterilization |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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