Kmedic
2 catalogue numbers from IPN013907, listed by Teleflex Medical LLC, United States, under Knife, Amputation. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GDN |
| Device type | Knife, Amputation |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2026-02-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 30.7 to 34.1 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN013907 | Length 30.7 cm | In distribution |
| IPN013908 | Length 34.1 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| American Medicals | American Medicals | 9 |
| Aesculap | Aesculap AG | 8 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 7 |
| Sklar® | Sklar Corporation | 6 |
| Ambler Surgical | Ambler Surgical, LLC | 4 |
| V. Mueller | Carefusion 2200, Inc. | 3 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 2 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 2 |
| gSource | Gsource, LLC. | 2 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 2 |
| V. Mueller | Steris Corporation | 2 |
| HNM Medical | HNM Stainless, LLC. | 2 |
Showing 12 of 21. All products under Knife, Amputation
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.