Identity
- Trade Name
- Quala FDA UDI
- Generic Name
- Dental x-ray film, non-screen FDA UDI
- Device Name
- Quala Intraoral X-ray Film QF58 Adult Speed FDA UDI
- Model / Reference
- 18310-QU FDA UDI
- Description
- Quala Intraoral X-ray Film QF58 Adult Speed FDA UDI
Identifiers
- Catalog Number
- 18310-QU FDA UDI
- Primary DI / UDI-DI
- D02318310QU10 FDA UDI
- FDA Product Code
- IWZ FDA UDI
- GMDN Term
- Dental x-ray film, non-screen FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1840 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental x-ray film, non-screen
Quala by National Distribution & Contracting, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental x-ray film, non-screen.
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- FILM DSS-58 D ADULT SINGLE FILM BUTTERFLY PACKETS D SPEED — Flow X-Ray Corp. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- DV-57 ADULT TWIN VALUE PAK — Flow X-Ray Corp. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- BUTTERFLY BARRIER FILM FSS-54 — Flow X-Ray Corp. · 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
- National Distribution & Contracting, Inc.
Sources (1)
- FDA UDI fe587c4c-626e-4545-8896-ee26f5c83fd3 36 fields · synced May 30, 2026