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Z-Guide Wire

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref C03 007 SModel Z-Guide Wire

by Z-Medical GmbH & Co. KG

Identity

Trade Name
Z-Guide Wire EUDAMEDFDA UDI
Generic Name
Orthopaedic bone staple drill bit FDA UDI
Device Name
Z-Guide Wire EUDAMED
Z-Guide Wire Ø1,5 x 80 mm FDA UDI
Model / Reference
C03 007 S EUDAMEDFDA UDI
Z-Guide Wire EUDAMED
Description
Z-Guide Wire Ø1,5 x 80 mm FDA UDI

Identifiers

Primary DI / UDI-DI
04057217003429 EUDAMEDFDA UDI
Basic UDI-DI
4057217Z-GUIDEWIRESAP EUDAMED
FDA Product Code
HTY FDA UDI
EMDN Code
V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
GMDN Term
Orthopaedic bone staple drill bit FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic bone staple drill bit

Z-Guide Wire by Z-Medical GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone staple drill bit.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Z-Medical GmbH & Co. KG

Sources (2)

  • FDA UDI 696077b2-2849-47c1-8f49-6d153b534a1a 34 fields · synced Sep 18, 2026
  • EUDAMED a1a2a0de-b3a2-4254-aecc-b38bc5f540ad 61 fields · synced Sep 18, 2026