K-Wire Guide Ø2.0mm, Proximal Humerus
EUDAMEDFDA UDIClass I (EU MDR)
by Medartis AG
Identity
- Trade Name
- K-Wire Guide Ø2.0mm, Proximal Humerus EUDAMEDAPTUS FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Guides EUDAMEDK-Wire Guide Ø2.0mm, Proximal Humerus FDA UDI
- Model / Reference
- A-2000 EUDAMEDFDA UDIP-2032.05 EUDAMED
- Description
- K-Wire Guide Ø2.0mm, Proximal Humerus FDA UDI
Identifiers
- Catalog Number
- A-2000 FDA UDI
- Primary DI / UDI-DI
- 07630037872733 EUDAMEDFDA UDI07630894823787 EUDAMED
- Basic UDI-DI
- 76300378007PE EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical retraction system, reusable
K-Wire Guide Ø2.0mm, Proximal Humerus by Medartis AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical retraction system, reusable.
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- Thompson — Thompson Surgical Instruments · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76300378007PE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (3)
- EUDAMED 2664212b-e822-46d1-b232-bc047616c9e2 61 fields · synced Jul 29, 2026
- FDA UDI 9bfde438-c87e-436d-9c62-e6394618a60d 34 fields · synced May 30, 2026
- EUDAMED 411588b3-7ba2-4b6f-a96c-3f3bb7ff0b6c 61 fields · synced Jul 15, 2026