Identity
- Trade Name
- American Medicals FDA UDI
- Generic Name
- Gastro-urological director FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B356HK250030 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Gastro-urological director 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: Gastro-urological director
American Medicals by American Medicals — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-urological director.
- V. Mueller — STERIS CORPORATION · Class I
- UNIVERSAL PROBE — SONTEC INSTRUMENTS, INC. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- PRINCETON — PRINCETON MEDICAL GROUP, INC. · Class I
- Probe With Eye — SONTEC INSTRUMENTS, INC. · Class I
- V. Mueller — STERIS CORPORATION · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- American Medicals
Sources (1)
- FDA UDI b8f57197-a882-4a9c-8d93-2a80958b72da 32 fields · synced May 30, 2026