Identity
- Trade Name
- BR Surgical, LLC FDA UDI
- Generic Name
- Middle ear pick FDA UDI
- Device Name
- ROSEN Needle (house-type), straight shaft, slightly curved blunt tip, 6-1/4" FDA UDI
- Model / Reference
- BR44-71616 FDA UDI
- Description
- ROSEN Needle (house-type), straight shaft, slightly curved blunt tip, 6-1/4" FDA UDI
Identifiers
- Catalog Number
- BR44-71616 FDA UDI
- Primary DI / UDI-DI
- 00840183501723 FDA UDI
- FDA Product Code
- JYT FDA UDI
- GMDN Term
- Middle ear pick FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Middle ear pick
BR Surgical, LLC by Br Surgical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Middle ear pick.
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- FENTEX — FENTEX medical GmbH · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- Integra® — Integra LifeSciences Production Corporation · Class I
- FENTEX — FENTEX medical GmbH · Class I
- SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Br Surgical Llc
Sources (1)
- FDA UDI 19e2e767-951f-42cf-b584-d1d1c689cd7f 35 fields · synced Jun 6, 2026