Synergetics
I-PACK Injection Kit With Speculum
67manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (26), Shanghai (11), Zhejiang (9). 12 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 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Winner Medical (Chongyang) Co., Ltd. | Chongyang | Hubei | Contract manufacturer | 13 |
| Wenzhou Baiyu Glasses Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Jiangsu Xuhe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 9 |
| Nanjing HI-Tech Tape Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 8 |
Showing 12 of 67. All 67 manufacturers in China registered for Kit, Surgical Instrument, Disposable
Record
| Listed by | Synergetics USA, Inc. |
|---|---|
| FDA product code | KDD |
| Device type | Kit, Surgical Instrument, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2020-05-31 |
| Record revised | 2025-09-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 59 to 77 °F |
| Packaging | Box of 10 |
| Distribution end date | 2025-08-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18069 | Withdrawn | |
| 18061 | Withdrawn | |
| 18060 | Withdrawn | |
| 18063 | Withdrawn | |
| 18069W | Withdrawn | |
| 18064 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 789 |
| CustomEyes® | Beaver-Visitec International, Ltd | 696 |
| DeRoyal | Deroyal Industries, Inc. | 589 |
| Centurion | Centurion Medical Products Corporation | 277 |
| Readypak Kit | Beaver-Visitec International, Ltd | 196 |
| Custom Healthcare Systems, Inc. | Manus Medical, LLC | 78 |
| Medical Action Industries | Medical Action Industries, Inc. | 76 |
| Bioseal Inc. | Bioseal | 38 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 37 |
| In2Bones | IN2BONES USA, LLC | 24 |
| Aero-Med | Aero-MED LLC | 23 |
| Medline | Medline Industries, Inc. | 17 |
Showing 12 of 252. All products under Kit, Surgical Instrument, Disposable
Recalls Naming This Product
8 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Synergetics, Inc. | UDI-DI | 2024-06-12 | Class I | Under Investigation by firm | Sterilization certificates could not be validated by the supplier | 14 units |
| Synergetics, Inc. | UDI-DI | 2024-06-12 | Class I | Under Investigation by firm | Sterilization certificates could not be validated by the supplier | 2 units |
| Synergetics, Inc. | UDI-DI | 2024-06-12 | Class I | Under Investigation by firm | Sterilization certificates could not be validated by the supplier | 116 units |
| Synergetics, Inc. | UDI-DI | 2024-06-12 | Class I | Under Investigation by firm | Sterilization certificates could not be validated by the supplier | 35 units |
| Microspecialties LLC | UDI-DI | 2024-06-05 | Class II | Release of Material/Component prior to receiving test results | Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. | 2316 units |
| Microspecialties LLC | UDI-DI | 2024-06-05 | Class II | Release of Material/Component prior to receiving test results | Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. | 96 units |
| Microspecialties LLC | UDI-DI | 2024-06-05 | Class II | Release of Material/Component prior to receiving test results | Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. | 780 units |
| Microspecialties LLC | UDI-DI | 2024-06-05 | Class II | Release of Material/Component prior to receiving test results | Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. | 804 units |
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.