Identity
- Trade Name
- ZIPSER PENIS CLAMP FDA UDI
- Generic Name
- Surgical penis clamp, reusable FDA UDI
- Device Name
- ZIPSER PENIS CLAMP FDA UDI
- Model / Reference
- 540-380 FDA UDI
- Description
- ZIPSER PENIS CLAMP FDA UDI
Identifiers
- Catalog Number
- 540-380 FDA UDI
- Primary DI / UDI-DI
- 00192896001565 FDA UDI
- FDA Product Code
- HFX FDA UDI
- GMDN Term
- Surgical penis clamp, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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
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
No
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, reusable
Zipser Penis Clamp by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical penis clamp, reusable.
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- Greenwald Surgical Company, Inc. — GRACE MANUFACTURING INC · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- AESCULAP — AESCULAP, INC. · Class II
- No-Scalpel Vasectomy — Femcare , Ltd. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 0792d265-3b66-4838-9b17-9640778d4817 35 fields · synced Jun 8, 2026