BR Surgical, LLC
Myringotomy Knife/Blade w/Handle, sterile, lance tip, angled, 5/box
1manufacturer
2catalogue numbers in this listing
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 | JYP |
| Device type | Knife, Myringotomy |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-04-03 |
| Record revised | 2023-05-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BR06-12436 | In distribution | |
| BR06-12435 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exmoor | Exmoor Plastics Limited | 116 |
| Integra® | Integra LifeSciences Production Corporation | 6 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 2 |
| Novo Surgical | Novo Surgical, Inc. | 2 |
| Adept Medical | Jedmed Instrument Company | 2 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 2 |
| MicroFrance® | Integra Microfrance SAS | 2 |
| Jedmed | Jedmed Instrument Company | 1 |
| Adept Medical Myringotomy Knife | Adept Medical Ltd | 1 |
| Intrace USA | Pilotis Tech LLC | 1 |
| Aesculap | Aesculap AG | 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.