Identity
- Trade Name
- American Medicals FDA UDI
- Generic Name
- Optical proctoscope, reusable FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B35669225220 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Optical proctoscope, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Microwave Radiation FDA UDI
Category: Optical proctoscope, reusable
American Medicals by American Medicals — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Optical proctoscope, reusable.
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- ESI — FTT MEDICAL, INC. · Class II
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- ESI — FTT MEDICAL, INC. · Class II
- HEINE® Proctoscope Tube — Heine Optotechnik GmbH & Co. KG · Class II
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
- American Medicals
Sources (1)
- FDA UDI c86e4355-003d-455d-8b14-e5457dcc2529 32 fields · synced May 31, 2026