Identity
- Trade Name
- BR Surgical, LLC FDA UDI
- Generic Name
- ENT surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Office Balloon Sinus Set, includes: Vienna Speculum, Bayonet fcp, Frontal Seeker, Maxillary Seeker, Freer elevator, Hartman-Noyes fcp, Frazier suct tube 5fr & 7fr, Filter, Paper Sterilization Indicators, and Sterilization tray w/mat 12"x5 1/2"x3" FDA UDI
- Model / Reference
- BR46-90000 FDA UDI
- Description
- Office Balloon Sinus Set, includes: Vienna Speculum, Bayonet fcp, Frontal Seeker, Maxillary Seeker, Freer elevator, Hartman-Noyes fcp, Frazier suct tube 5fr & 7fr, Filter, Paper Sterilization Indicators, and Sterilization tray w/mat 12"x5 1/2"x3" FDA UDI
Identifiers
- Catalog Number
- BR46-90000 FDA UDI
- Primary DI / UDI-DI
- 00840183527723 FDA UDI
- FDA Product Code
- OGR FDA UDI
- GMDN Term
- ENT surgical procedure kit, non-medicated, reusable 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENT surgical procedure kit, non-medicated, reusable
BR Surgical, LLC by Br Surgical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Br Surgical Llc
Sources (1)
- FDA UDI 5eebe6dd-e3e4-44ae-8c7f-063843a9e24c 35 fields · synced May 31, 2026