Identity
- Trade Name
- Amtouch Barrier Envelopes FDA UDI
- Generic Name
- X-ray film cassette, manual FDA UDI
- Device Name
- Barrier Envelopes, Top Open, Size #1 (100/Box) FDA UDI
- Model / Reference
- Top Open - Size 1 FDA UDI
- Description
- Barrier Envelopes, Top Open, Size #1 (100/Box) FDA UDI
Identifiers
- Catalog Number
- AMBE-1 FDA UDI
- Primary DI / UDI-DI
- 00850058951393 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
Amtouch Barrier Envelopes by American Medical & Hospital Supply Co., Inc. — 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
- American Medical & Hospital Supply Co., Inc.
Sources (1)
- FDA UDI e62028ad-ff56-44e7-9625-a620cd3e310c 34 fields · synced May 30, 2026