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Needle Holders, Tip Crile-Wood Style, Short, Smooth
EUDAMEDFDA UDIClass I (EU MDR)
Ref 03.520.018
Identity
- Trade Name
- Depuy Synthes FDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Needle Holders, Tip Crile-Wood Style, Short, Smooth EUDAMEDNeedle Holder, Crile-Wood Style, Short, Smooth FDA UDI
- Model / Reference
- 03.520.018 EUDAMEDFDA UDI
- Description
- Needle Holder, Crile-Wood Style, Short, Smooth FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776028268 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190776CLAMPQX EUDAMED
- Direct Marketing DI
- 00190776028268 EUDAMED
- FDA Product Code
- MDM 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
- 878.4800 FDA UDI
- Market of Registration
- Bulgaria 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
Yes
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
Needle Holders, Tip Crile-Wood Style, Short, Smooth by AVALIGN TECHNOLOGIES, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Suturing needle holder, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0190776CLAMPQX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Avalign Technologies Inc.
- EUDAMED SRN
- US-MF-000008511
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 16719876-5ff9-4cea-824b-315538106f5f 61 fields · synced Jul 9, 2026
- FDA UDI 4c3e4f42-4373-4b10-af9c-56176ce6ed09 34 fields · synced May 30, 2026