Sklar®
Bunnell Tendon Stripper 6MM 6 Inches
3manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), 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 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | GAI |
| Device type | Stripper, Vein, Reusable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-21 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 69-2064 | In distribution | |
| 40-9863 | In distribution | |
| 69-2014 | In distribution | |
| 47-3297 | In distribution | |
| 69-2065 | In distribution | |
| 47-3410 | In distribution | |
| 47-3411 | In distribution | |
| 69-2053 | In distribution | |
| 69-2060 | In distribution | |
| 69-2019 | In distribution | |
| 47-3406 | In distribution | |
| 69-2057 | In distribution | |
| 47-3295 | In distribution | |
| 69-2055 | In distribution | |
| 47-3294 | In distribution | |
| 47-3404 | In distribution | |
| 47-3414 | In distribution | |
| 40-9862 | In distribution | |
| 69-2067 | In distribution | |
| 47-3403 | In distribution | |
| 69-2050 | In distribution | |
| 40-9866 | In distribution | |
| 47-3405 | In distribution | |
| 69-2054 | In distribution | |
| 69-2020 | In distribution | |
| 69-2066 | In distribution | |
| 40-9865 | In distribution | |
| 69-2056 | In distribution | |
| 69-2052 | In distribution | |
| 47-3412 | In distribution | |
| 69-2068 | In distribution | |
| 69-2062 | In distribution | |
| 69-2061 | In distribution | |
| 69-2059 | In distribution | |
| 69-2013 | In distribution | |
| 69-2058 | In distribution | |
| 47-3296 | In distribution | |
| 69-2063 | In distribution | |
| 47-3407 | In distribution | |
| 69-2021 | In distribution | |
| 47-3298 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atramat | Internacional Farmacéutica S.A DE C.V | 44 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 44 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 39 |
| Surtex | Surtex Instruments Ltd | 17 |
| Aesculap | Aesculap AG | 17 |
| Stripper | KLS-Martin L.P. | 9 |
| Millennium | Avalign Technologies, Inc. | 9 |
| Hayden Medical | Hayden Medical Inc | 6 |
| V. Mueller | Steris Corporation | 6 |
| BR Surgical, LLC | BR Surgical LLC | 5 |
| HNM Medical | HNM Stainless, LLC. | 4 |
| V. Mueller | Carefusion 2200, Inc. | 4 |
Showing 12 of 24. All products under Stripper, Vein, Reusable
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.