Hu-Friedy
Infinity Cassette 12 Instruments, Orange, 2 Elevators, 4 Clips AND 2 AW
105manufacturers in China registered for this device type
438catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument
Record
| Listed by | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | FSM |
| Device type | Tray, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-04-21 |
| Record revised | 2023-06-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-04-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IM8128HNYU | In distribution | |
| IMN467COAN | In distribution | |
| IM8129E1L | In distribution | |
| IME12DO217 | In distribution | |
| IMNOS208FA | In distribution | |
| IM5083C2 | In distribution | |
| IMOS203AW2 | In distribution | |
| IMN5811-FM | In distribution | |
| IMN41611C4 | In distribution | |
| IMN8129LP | In distribution | |
| IM4200MWU | In distribution | |
| IM8128-OR | In distribution | |
| IM4200-AW | In distribution | |
| IM4226LP3 | In distribution | |
| IMN6052ECR | In distribution | |
| IMOS205ONF | In distribution | |
| IMN5084-FM | In distribution | |
| IMN4221-LP | In distribution | |
| IMN6053-AN | In distribution | |
| IMN8129ELN | In distribution | |
| IMOS289E2L | In distribution | |
| IMN5088NH | In distribution | |
| IMN60HCD | In distribution | |
| IMNORTL4C2 | In distribution | |
| IMN8126C2N | In distribution | |
| IM8128E1L | In distribution | |
| IMNOS20C | In distribution | |
| IM9208-AW2 | In distribution | |
| IM4209AWC8 | In distribution | |
| IMNO206-C4 | In distribution | |
| IMN5101-AW | In distribution | |
| I1CLPC8A3 | In distribution | |
| IMNOS0C6 | In distribution | |
| IM58FMC2 | In distribution | |
| IM4168CO2 | In distribution | |
| IMN4164NH | In distribution | |
| IM908WRCH | In distribution | |
| IMNOS6CE1L | In distribution | |
| IMIQ38LM | In distribution | |
| IMEDIN211O | In distribution | |
| IMOS200CRA | In distribution | |
| I138CLE7AW | In distribution | |
| IME12DO213 | In distribution | |
| IMOS280ELA | In distribution | |
| IMN4169C4 | In distribution | |
| IM4128HFM | In distribution | |
| IMN4128ECN | In distribution | |
| IMNOS28AC4 | In distribution | |
| IMN4126C2O | In distribution | |
| IME12DO218 | In distribution | |
| IMN4205CNA | In distribution | |
| IM8125HE2L | In distribution | |
| IM4163C4AF | In distribution | |
| IME12111C2 | In distribution | |
| IM4121LM | In distribution | |
| IMN4167C4 | In distribution | |
| IM9143-AW | In distribution | |
| IMOS28CC6 | In distribution | |
| IMPCMKIT4 | In distribution | |
| IM4203CE5L | In distribution | |
| IMN41611FM | In distribution | |
| IM53HFM | In distribution | |
| IM5109-AW | In distribution | |
| IMS3116AW2 | In distribution | |
| IMN9142HAS | In distribution | |
| IMN829ELNA | In distribution | |
| IMN8125ELN | In distribution | |
| IMEDIN208O | In distribution | |
| IMNOS238AC | In distribution | |
| IMN4124C2O | In distribution | |
| IM5089C2 | In distribution | |
| IM64IQ0 | In distribution | |
| TCAFKIT | In distribution | |
| IMN4120C2O | In distribution | |
| IME12O2110 | In distribution | |
| IMN4148C4 | In distribution | |
| IM5086AW | In distribution | |
| IMOS206 | In distribution | |
| IM4169C4AF | In distribution | |
| IMN4211CEL | In distribution | |
| IMOS16-C2 | In distribution | |
| IM4162C4E3 | In distribution | |
| IM4129HCER | In distribution | |
| IMIQ38FM | In distribution | |
| IMN8121OC1 | In distribution | |
| IMOS287E7L | In distribution | |
| IM9141AWNH | In distribution | |
| IMN6050ECR | In distribution | |
| IMN5088CFM | In distribution | |
| IM8128HE2L | In distribution | |
| IM4166C4AF | In distribution | |
| IMEDIN203O | In distribution | |
| IM4163NHC4 | In distribution | |
| I132C10AW2 | In distribution | |
| IMN4167C2 | In distribution | |
| IMOS200AC6 | In distribution | |
| IMOSH149AN | In distribution | |
| IMN5058E2 | In distribution | |
| IMOS288ELP | In distribution | |
| IM4160C4AF | In distribution | |
| IMN4165C2N | In distribution | |
| IMN8125C4 | In distribution | |
| IMOS200ONF | In distribution | |
| IMN4123ECA | In distribution | |
| IMN908WRCH | In distribution | |
| IM9086/AW | In distribution | |
| IMOS9E2RCN | In distribution | |
| IME12D11C2 | In distribution | |
| IMN4120C2 | In distribution | |
| IM4225LP3 | In distribution | |
| IMN5088C2 | In distribution | |
| IMEDIN207O | In distribution | |
| IM8129HE2L | In distribution | |
| IMOS9E2CLF | In distribution | |
| IMN4127C4A | In distribution | |
| IME12110C2 | In distribution | |
| IMOS208AW2 | In distribution | |
| IMOS2865EL | In distribution | |
| IMN5103C2F | In distribution | |
| I135C4FMA2 | In distribution | |
| IMN6058ECR | In distribution | |
| IMN4167NH | In distribution | |
| IMN8128OC0 | In distribution | |
| IM9148ORAW | In distribution | |
| IM9143PWR | In distribution | |
| IM41610-C4 | In distribution | |
| IMOS209LP | In distribution | |
| I130C10ELA | In distribution | |
| IMN4611AC4 | In distribution | |
| IM55FMC2 | In distribution | |
| IMN30HECR7 | In distribution | |
| IMN4041C12 | In distribution | |
| IMN4203C4 | In distribution | |
| IM5080E4 | In distribution | |
| IMN4120C2F | In distribution | |
| IMOS289ELA | In distribution | |
| IM4120LM | In distribution | |
| IMN41211NH | In distribution | |
| IMNOS280LP | In distribution | |
| ISRG3EC10A | In distribution | |
| I139CLE7AW | In distribution | |
| IMN5085ECR | In distribution | |
| IM9140-AW | In distribution | |
| I98H8NC6O2 | In distribution | |
| IMN30HECR6 | In distribution | |
| IM5108-AW | In distribution | |
| IMN8126HNA | In distribution | |
| I1365-C10 | In distribution | |
| I133C12LPA | In distribution | |
| IM4165C4AF | In distribution | |
| IME12DO215 | In distribution | |
| IMN6054NH | In distribution | |
| IM416CC4 | In distribution | |
| IM8126HNH | In distribution | |
| IMN4163NH | In distribution | |
| IM5105-FM | In distribution | |
| IM4129ECON | In distribution | |
| IMOS1-FM | In distribution | |
| IM5101H-FM | In distribution | |
| I138C10EAL | In distribution | |
| IMN4203C6 | In distribution | |
| IMN4128C2F | In distribution | |
| IMN4165NH | In distribution | |
| IMOS8E8C2 | In distribution | |
| IM8126E1L | In distribution | |
| IM59FMC2 | In distribution | |
| IMN5104NH | In distribution | |
| IM8125E1L | In distribution | |
| IMOS208C8 | In distribution | |
| IMN91410NH | In distribution | |
| IM5100NHC2 | In distribution | |
| IM8223E10 | In distribution | |
| IMNOS249NC | In distribution | |
| IMN5107-AW | In distribution | |
| IM4163C4RD | In distribution | |
| I133C4FMA2 | In distribution | |
| IMN8125-AW | In distribution | |
| IMNO24511C | In distribution | |
| IMN5086-FM | In distribution | |
| IM51FM | In distribution | |
| I130C10EAL | In distribution | |
| IM50FMC2 | In distribution | |
| IM4208AWC8 | In distribution | |
| IMOS3C4E2N | In distribution | |
| I133C10EAL | In distribution | |
| IMOS209ONF | In distribution | |
| IMN42011LP | In distribution | |
| IM4205LP3 | In distribution | |
| IMN30HECR2 | In distribution | |
| IMN4043C12 | In distribution | |
| I98H0C4 | In distribution | |
| IM4167CO2N | In distribution | |
| IM4169ECAN | In distribution | |
| IM4205-AW | In distribution | |
| IME12D13C2 | In distribution | |
| IM4168HNH | In distribution | |
| IMN4163EC4 | In distribution | |
| IM4228LP3 | In distribution | |
| I13C4 | In distribution | |
| IMN8124-A1 | In distribution | |
| Kit-1-Comp | In distribution | |
| IM8126BU | In distribution | |
| IM4125LM | In distribution | |
| IMN6032D | In distribution | |
| I130CE4LP | In distribution | |
| IMN4166NH | In distribution | |
| IMN416CNH | In distribution | |
| IM4161NAW | In distribution | |
| I130CE2LNA | In distribution | |
| IMEDIN204O | In distribution | |
| IM4121C4 | In distribution | |
| IMN5109-AW | In distribution | |
| IMN4167EC4 | In distribution | |
| IMOS0E2CLR | In distribution | |
| IMOS200CNF | In distribution | |
| IMN510C-AW | In distribution | |
| IM4080C6AN | In distribution | |
| IMNOS5ALLF | In distribution | |
| IM6053ECR | In distribution | |
| IM8127E2 | In distribution | |
| IMEDIN205O | In distribution | |
| IM6050-A1 | In distribution | |
| IMN41611HF | In distribution | |
| IM4203-AW | In distribution | |
| IMN60IQ3 | In distribution | |
| IMN30HECR4 | In distribution | |
| IMN41637CF | In distribution | |
| IMN4128C2 | In distribution | |
| IM56FMC2 | In distribution | |
| IMN6058AW | In distribution | |
| AZIMENDOKIT | In distribution | |
| IMN9146SSN | In distribution | |
| IMN6051-AN | In distribution | |
| IME12DO214 | In distribution | |
| IMN9411AW2 | In distribution | |
| IMN4049C12 | In distribution | |
| IM5108LP3 | In distribution | |
| IMOS6ELP | In distribution | |
| IM9080AW | In distribution | |
| IMOSH8E1AN | In distribution | |
| IMN30HECR8 | In distribution | |
| IMOSH200NA | In distribution | |
| IMOS208ONF | In distribution | |
| IMNOS208H | In distribution | |
| IM4168AWC6 | In distribution | |
| IMEDIN210O | In distribution | |
| IM6053-A1 | In distribution | |
| IM5109-LP | In distribution | |
| IM4123FNC2 | In distribution | |
| IMN5057E2 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IMS | HU-Friedy MFG Co., LLC | 2,710 |
| Tray, Surgical, Instrument | Synthes Gmbh | 1,052 |
| Tray, Surgical, Instrument | Medtronic Sofamor Danek, Inc. | 1,012 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 666 |
| Aptus | Medartis Inc. | 588 |
| Acumed | Acumed LLC | 566 |
| Aesculap | Aesculap AG | 532 |
| Sklar | Sklar Corporation | 465 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 429 |
| Level ONE | KLS-Martin L.P. | 341 |
| Bahadir USA | Bahadir USA LLC | 300 |
| Devon | Cardinal Health | 254 |
Showing 12 of 3,212. All products under Tray, Surgical, Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K844002 | 1984-11-08 |
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.