Aesculap
Ring Stripper, 22" (550 mm), diam. 8,50 mm, without handle
3manufacturers in China registered for this device type
17catalogue 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 | Aesculap AG, Germany |
|---|---|
| FDA product code | GAI |
| Device type | Stripper, Vein, Reusable |
| 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 | 2020-04-22 |
| Record revised | 2021-07-20 (version 2) |
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 |
| Distribution end date | 2021-04-23 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FB108R | In distribution | |
| FB112R | In distribution | |
| FB115R | In distribution | |
| FB109R | In distribution | |
| FB116R | In distribution | |
| FB114R | In distribution | |
| FB119R | In distribution | |
| FB110R | In distribution | |
| FB117R | In distribution | |
| FB113R | In distribution | |
| FB055R | Withdrawn | |
| FB037R | Withdrawn | |
| FB035R | Withdrawn | |
| FB038R | Withdrawn | |
| FB053R | Withdrawn | |
| FB054R | Withdrawn | |
| FB036R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atramat | Internacional Farmacéutica S.A DE C.V | 44 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 44 |
| Sklar® | Sklar Corporation | 41 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 39 |
| Surtex | Surtex Instruments Ltd | 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.