Ambler Value Line
Lewis lens loop, 5 3/8'', small 5.0mm x 6.0mm smooth loop, flat handle, economy pattern recommended for clinics/mission trips only
1manufacturer
1catalogue number
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 |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Lewis lens loop | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 15 |
| 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 |
| 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.