Identity
- Trade Name
- ELMED FDA UDI
- Generic Name
- Circumcision kit, reusable FDA UDI
- Device Name
- TEFLON RINGS FOR GOMCO 10/PK FDA UDI
- Model / Reference
- ST3155TR FDA UDI
- Description
- TEFLON RINGS FOR GOMCO 10/PK FDA UDI
Identifiers
- Catalog Number
- ST3155TR FDA UDI
- Primary DI / UDI-DI
- 00198506002717 FDA UDI
- FDA Product Code
- KOA FDA UDIHFB FDA UDI
- GMDN Term
- Circumcision kit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 FDA UDI884.4530 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Elmed Incorporated
Sources (1)
- FDA UDI e00685d7-d4a1-4f94-9a21-588703c7c66b 36 fields · synced Jun 1, 2026