Ambler Surgical
Gills-Welsh lens loop, 4 7/8'', ultra thin, slightly curved, smooth 5.0mm x 7.0mm loop, with olive tip on opposite end, flat handle
1manufacturer
15catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | HNE |
| Device type | Snare, Enucleating |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
| Record revised | 2023-02-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Gills-Welsh lens loop | In distribution | |
| Gills-Welsh lens loop | In distribution | |
| Keener-Alt lens loop | In distribution | |
| Lewis lens loop | In distribution | |
| Simcoe nucleus loop | In distribution | |
| Lewis lens loop | In distribution | |
| New Orleans eye and ear lens loop | In distribution | |
| Gills-Welsh modified lens loop | In distribution | |
| Foster enucleation snare with ratcheting wing-nut handle to draw wire | In distribution | |
| Lewis lens loop | In distribution | |
| Lewis lens loop | In distribution | |
| Kansas lens loop | In distribution | |
| Wilder lens loop | In distribution | |
| Foster enucleation snare wire | In distribution | |
| Kirby intra-capsular lens loop | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 9 |
| Novo Surgical | Novo Surgical, Inc. | 4 |
| Snare, Enucleating | Geuder Aktiengesellschaft | 3 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 3 |
| Avalign | Avalign Technologies, Inc. | 2 |
| Pilling | Teleflex Medical LLC | 2 |
| Symmetry Lewis | Aspen Surgical Products, Inc. | 2 |
| V. Mueller | Steris Corporation | 2 |
| Symmetry Simcoe | Aspen Surgical Products, Inc. | 1 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 1 |
| Ambler Value Line | Ambler Surgical, LLC | 1 |
| Symmetry Wilder | Aspen Surgical Products, Inc. | 1 |
Showing 12 of 13. All products under Snare, Enucleating
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.