Identity
- Trade Name
- Paul Banditt FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- BANDITT MICRO NEEDLE HOLDER WITH LOCK, STRAIGHT HANDLE, TC INSERT, 17.5MM, STRAIGHT, For suture size 4/0-8/0 FDA UDI
- Model / Reference
- NHCITWST FDA UDI
- Description
- BANDITT MICRO NEEDLE HOLDER WITH LOCK, STRAIGHT HANDLE, TC INSERT, 17.5MM, STRAIGHT, For suture size 4/0-8/0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D955NHCITWST1 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Suturing needle holder, reusable
Paul Banditt by Terlain Enterprises, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Terlain Enterprises, Inc.
Sources (1)
- FDA UDI 2e3a7890-7487-4601-aaf5-9c54d8623e2e 33 fields · synced Jun 1, 2026