RZ Medizintechnik GmbH

FDA UDI

Class I (US FDA UDI)

by RZ-Medizintechnik GmbH

Identity

Trade Name: RZ Medizintechnik GmbH FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: Vascular TC Mini NeedleHolder Ø3,5mm, straight, 2x6mm, with ratchet WL 170mm, golfball handle, gold FDA UDI
Model / Reference: 295-034-200 FDA UDI
Description: Vascular TC Mini NeedleHolder Ø3,5mm, straight, 2x6mm, with ratchet WL 170mm, golfball handle, gold FDA UDI

Identifiers

Catalog Number: 295-034-200 FDA UDI
Primary DI / UDI-DI: 04049197532341 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Suturing needle holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.4500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Suturing needle holder, reusable

RZ Medizintechnik GmbH by RZ-Medizintechnik GmbH — 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: RZ-Medizintechnik GmbH

Sources (1)

FDA UDI 4c30fc87-c1ea-4512-a39a-6d467caa6c36 35 fields · synced Jun 1, 2026