Identity
- Trade Name
- FV-54 CHILD PEDO PAK FDA UDI
- Generic Name
- Dental x-ray film, non-screen FDA UDI
- Device Name
- F Speed, Size 0, 100 Single Film Packets. FDA UDI
- Model / Reference
- 18635 FDA UDI
- Description
- F Speed, Size 0, 100 Single Film Packets. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812045031013 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
Yes
FDA UDI
Category: Dental x-ray film, non-screen
Fv-54 Child Pedo Pak by Flow X-Ray Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental x-ray film, non-screen.
- INSIGHT — CARESTREAM HEALTH, INC. · Class I
- D-Speed — CARESTREAM HEALTH, INC. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- D-Speed — CARESTREAM HEALTH, INC. · Class I
- Ultra-speed — CARESTREAM HEALTH, INC. · Class I
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Flow X-Ray Corp.
Sources (1)
- FDA UDI c4664c14-5926-4dd8-b9e4-0de17a043b4a 33 fields · synced May 29, 2026