Identity
- Trade Name
- XPRESS- FV-57 FRESH PAK FDA UDI
- Generic Name
- Dental x-ray film, non-screen FDA UDI
- Device Name
- F SPEED SIZE 2 ADULT FILMS, 2 FILMS PER PACKET, 100 DOUBLE FILMS PER BOX. FDA UDI
- Model / Reference
- 18621 FDA UDI
- Description
- F SPEED SIZE 2 ADULT FILMS, 2 FILMS PER PACKET, 100 DOUBLE FILMS PER BOX. FDA UDI
Identifiers
- Primary DI / UDI-DI
- H665186211 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
- 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
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
Xpress- Fv-57 Fresh Pak by Flow X-Ray Corp. — 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
- Flow X-Ray Corp.
Sources (1)
- FDA UDI bd986c7d-e693-494a-8647-77ba5dc64ca5 34 fields · synced May 30, 2026