Identity
- Trade Name
- Instrapac FDA UDI
- Generic Name
- Mouth gag, non-adjustable FDA UDI
- Device Name
- Instrapac Intraoral Mouth Prop Small x 40 FDA UDI
- Model / Reference
- 8811 FDA UDI
- Description
- Instrapac Intraoral Mouth Prop Small x 40 FDA UDI
Identifiers
- Catalog Number
- 8811 FDA UDI
- Primary DI / UDI-DI
- 05010058088115 FDA UDI
- FDA Product Code
- EIG FDA UDI
- GMDN Term
- Mouth gag, non-adjustable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mouth gag, non-adjustable
Instrapac by Robinson Healthcare Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
- 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
- Robinson Healthcare Limited
Sources (1)
- FDA UDI 369b790f-6766-4c6e-b482-7f7c9263c899 36 fields · synced May 30, 2026