BR Surgical, LLC
DERLACKI Ossicle Holder,1.5mm x 4mm vertical groove,1.5mm x 2mm horizontal groove, 1mm teeth, 4 3/4"
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | BR Surgical LLC, United States |
|---|---|
| FDA product code | JYF |
| Device type | Clamp, Ossicle Holding |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BR12-18412 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® | Integra LifeSciences Production Corporation | 3 |
| Ambler Surgical | Ambler Surgical, LLC | 2 |
| Aesculap | Aesculap AG | 2 |
| Novo Surgical | Novo Surgical, Inc. | 2 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 2 |
| V. Mueller | Steris Corporation | 1 |
| Symmetry Sheehy | Aspen Surgical Products, Inc. | 1 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 1 |
| Pilling | Teleflex Medical LLC | 1 |
| Jedmed | Jedmed Instrument Company | 1 |
| Millennium | Avalign Technologies, Inc. | 1 |
| Symmetry Derlacki | Aspen Surgical Products, Inc. | 1 |
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.