Identity
- Trade Name
- Teeth Screw Driver FDA UDI
- Generic Name
- Mouth gag, non-adjustable FDA UDI
- Device Name
- A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. FDA UDI
- Model / Reference
- PN-2002 FDA UDI
- Description
- A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872108795 FDA UDI
- FDA Product Code
- KBW 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
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mouth gag, non-adjustable
Teeth Screw Driver by Enter Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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
- Enter Medical Corporation
Sources (1)
- FDA UDI 9ab886ed-d2cc-43e5-95ce-d9da49a36e02 33 fields · synced Jun 1, 2026