Identity
- Trade Name
- BR Surgical, LLC FDA UDI
- Generic Name
- Mouth gag, non-adjustable FDA UDI
- Device Name
- Mouth prop, regular, for adults, without chain, plastic coated metal frame FDA UDI
- Model / Reference
- BR48-13054 FDA UDI
- Description
- Mouth prop, regular, for adults, without chain, plastic coated metal frame FDA UDI
Identifiers
- Catalog Number
- BR48-13054 FDA UDI
- Primary DI / UDI-DI
- 00840183512569 FDA UDI
- FDA Product Code
- KBN FDA UDI
- GMDN Term
- Mouth gag, non-adjustable 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mouth gag, non-adjustable
BR Surgical, LLC by Br Surgical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mouth gag, non-adjustable.
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- Plasdent — PLASDENT CORP. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- MOUTH PROP ADULT BITE BLOCK WITHOUT ATTACHMENT BEAUDRY STYLE — W.H. Holden, Inc. · Class I
- Surgical Direct — SURGICAL DIRECT, 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 |
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Manufacturer
- Manufacturer
- Br Surgical Llc
Sources (1)
- FDA UDI d9a6e2ee-6121-453f-a214-7859d5c71bf1 35 fields · synced Jun 1, 2026