Identity
- Trade Name
- Plasdent FDA UDI
- Generic Name
- X-ray film cassette, manual FDA UDI
- Device Name
- Soft Barrier Envelopes, Easy-Tear, For Phosphor Plates, #2 FDA UDI
- Model / Reference
- BE-002S FDA UDI
- Description
- Soft Barrier Envelopes, Easy-Tear, For Phosphor Plates, #2 FDA UDI
Identifiers
- Catalog Number
- BE-002S FDA UDI
- Primary DI / UDI-DI
- D832BE002S1 FDA UDI
- FDA Product Code
- PEM FDA UDI
- GMDN Term
- X-ray film cassette, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: X-ray film cassette, manual
Plasdent by Plasdent Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Plasdent Corp.
Sources (1)
- FDA UDI 87122e59-0ae6-4a4c-9a68-97a60c374486 34 fields · synced May 30, 2026