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Castroviejo Needle Holder, Straight
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref E3862Ref E3850Ref E3861
Identity
- Trade Name
- Castroviejo Needle Holder, Straight EUDAMEDFDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- Reusable Needle Holders EUDAMED
- Model / Reference
- E3862 EUDAMEDFDA UDIE3861 EUDAMEDFDA UDIE3850 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058935011772 EUDAMEDFDA UDI04058935011758 EUDAMEDFDA UDI04058935011734 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04058935011772 EUDAMEDB-04058935011734 EUDAMEDB-04058935011758 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
Castroviejo Needle Holder, Straight by Bausch & Lomb, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (6)
- FDA UDI 489f9646-78da-4d33-bbfc-965f53d6ec1b 32 fields · synced Jul 29, 2026
- FDA UDI 416b010b-ae6c-4087-9a69-ee8abc2b3e0c 32 fields · synced May 29, 2026
- FDA UDI 2b91b288-0dbd-46a2-a09f-397d2e5e4746 32 fields · synced May 30, 2026
- EUDAMED 4ae9dedb-9bc4-4f35-835a-943606939451 61 fields · synced Jul 15, 2026
- EUDAMED b63376b5-9d19-4311-8019-82cb3d14ac53 61 fields · synced Jul 20, 2026
- EUDAMED 79b028de-448a-470a-8f21-d77f2af68c60 61 fields · synced Jul 29, 2026