Identity
- Trade Name
- BR Surgical, LLC FDA UDI
- Generic Name
- ENT cabinet FDA UDI
- Device Name
- OTOSMART ENT Treatment Cabinet, 3 drawers, built-in pressure/suction pump, 35 1/4"w x 36 1/2"h x 19 3/4"d FDA UDI
- Model / Reference
- BR900-7509 FDA UDI
- Description
- OTOSMART ENT Treatment Cabinet, 3 drawers, built-in pressure/suction pump, 35 1/4"w x 36 1/2"h x 19 3/4"d FDA UDI
Identifiers
- Catalog Number
- BR900-7509 FDA UDI
- Primary DI / UDI-DI
- 00840183528508 FDA UDI
- FDA Product Code
- ETF FDA UDI
- GMDN Term
- ENT cabinet FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.5300 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENT cabinet
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 4435a1d1-26bc-4413-a0ef-cbe0789b89de 35 fields · synced Jun 6, 2026