Identity
- Trade Name
- AccuFilm® FDA UDI
- Generic Name
- Dental articulation paper FDA UDI
- Device Name
- AccuFilm® II Booklet Red/Black (5 Booklets of 50) FDA UDI
- Model / Reference
- Red/Black Booklet FDA UDI
- Description
- AccuFilm® II Booklet Red/Black (5 Booklets of 50) FDA UDI
Identifiers
- Catalog Number
- S053 FDA UDI
- Primary DI / UDI-DI
- M595S0532 FDA UDI
- FDA Product Code
- EFH FDA UDI
- GMDN Term
- Dental articulation paper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6140 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AccuFilm® by Parkell, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Parkell, Inc.
Sources (1)
- FDA UDI 5ba1b819-15cb-482c-88bb-005a88a4f25d 36 fields · synced May 31, 2026