Identity
- Trade Name
- HELMUT ZEPF FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- HOLDER, NEEDLE DERF, NEEDLE HOLDER WITH TC-JAWS, 12 CM FDA UDI
- Model / Reference
- 41.362.12 FDA UDI
- Description
- HOLDER, NEEDLE DERF, NEEDLE HOLDER WITH TC-JAWS, 12 CM FDA UDI
Identifiers
- Catalog Number
- 41.362.12 FDA UDI
- Primary DI / UDI-DI
- EZPF41362120 FDA UDI
- FDA Product Code
- FHQ FDA UDI
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suturing needle holder, reusable
A handheld manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing.
Similar devices
Also classified as Suturing needle holder, reusable.
- JACOBSON NEEDLE HOLDER — SONTEC INSTRUMENTS, INC. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- HNM Medical — HNM STAINLESS, LLC. · Class I
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · 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
- Helmut Zepf Medizintechnik GmbH
Sources (1)
- FDA UDI 20295cd5-26fc-4943-9607-06f8e66d4c52 35 fields · synced Jun 23, 2026