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Troutman Needle Holder, Curved
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref E3839 XWH
Identity
- Trade Name
- Troutman Needle Holder, Curved EUDAMEDFDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Reusable Needle Holders EUDAMED
- Model / Reference
- E3839 XWH EUDAMEDFDA UDIE3839 X FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058935011666 EUDAMEDFDA UDI04058935011659 FDA UDI
- Basic UDI-DI
- B-04058935011666 EUDAMED
- FDA Product Code
- HNM 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
- 886.4350 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suturing needle holder, reusable
Troutman Needle Holder, Curved by Bausch & Lomb, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Suturing needle holder, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (3)
- FDA UDI 9acd3989-ef4f-4a10-ab6f-4d02e539902d 32 fields · synced Jul 16, 2026
- FDA UDI ceafb77f-aa7c-4423-8e4b-a0a0f978f860 32 fields · synced May 30, 2026
- EUDAMED f92706b5-7cde-4fbf-9618-c2d752a8e6a5 61 fields · synced Jul 16, 2026