Identity
- Trade Name
- devemed FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Needleholders (Rotary Catch) EUDAMEDNeedle holder "Mathieu-Olsen" | 17 cm with scissors and double spring TC, rotary catch, 2-0 - 4-0 FDA UDI
- Model / Reference
- 1067-17 EUDAMEDFDA UDI
- Description
- Needle holder "Mathieu-Olsen" | 17 cm with scissors and double spring TC, rotary catch, 2-0 - 4-0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061644025053 EUDAMEDFDA UDI
- Basic UDI-DI
- 4061644PG020102ZU EUDAMED
- Direct Marketing DI
- 04061644025053 EUDAMED
- FDA Product Code
- HXK FDA UDI
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
devemed by devemed GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- devemed GmbH
Sources (2)
- FDA UDI 698700ee-3793-4106-a7cb-0f32881f0c60 34 fields · synced Aug 1, 2026
- EUDAMED 12498897-f0ea-41c7-89ab-b5b2e341f281 61 fields · synced Aug 1, 2026