Identity
- Trade Name
- Medline Industries, Inc. FDA UDI
- Generic Name
- Surgical penis clamp, single-use FDA UDI
- Device Name
- STERILE GOMCO 1.3 FDA UDI
- Model / Reference
- DYNDA1264 FDA UDI
- Description
- STERILE GOMCO 1.3 FDA UDI
Identifiers
- Catalog Number
- DYNDA1264 FDA UDI
- Primary DI / UDI-DI
- 10888277538399 FDA UDI
- FDA Product Code
- OFF FDA UDI
- GMDN Term
- Surgical penis clamp, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1140 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical penis clamp, single-use
Medline Industries, Inc. by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical penis clamp, single-use.
- PENIS CLAMP — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- Centurion — Centurion Medical Products · Class II
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- ShangRing — Wuhu Snnda Medical Treatment Appliance Technology · Class II
- Centurion — Centurion Medical Products · Class II
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Centurion — Centurion Medical Products · Class II
- ShangRing — Wuhu Snnda Medical Treatment Appliance Technology · 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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 6fc2a9b3-b550-425b-b0a9-6f1da571d80e 35 fields · synced May 30, 2026