Identity
- Trade Name
- HEINE® Proctoscope Tube FDA UDI
- Generic Name
- Optical proctoscope, reusable FDA UDI
- Model / Reference
- 000 FDA UDI
Identifiers
- Catalog Number
- E-000.19.114 FDA UDI
- Primary DI / UDI-DI
- 04053755126132 FDA UDI
- FDA Product Code
- GCM FDA UDI
- GMDN Term
- Optical proctoscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Category: Optical proctoscope, reusable
HEINE® Proctoscope Tube by Heine Optotechnik GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Optical proctoscope, reusable.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- ESI — FTT MEDICAL, INC. · Class II
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- American Medicals — AMERICAN MEDICALS · Class I
- ESI — FTT MEDICAL, INC. · Class II
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- ESI — FTT MEDICAL, INC. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heine Optotechnik GmbH & Co. KG
Sources (1)
- FDA UDI 05dd76b0-4a9f-4c1b-90bc-4174c0babf5d 34 fields · synced Jun 1, 2026