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Ophthalmic Blade Handles, Collets & Wrenches
EUDAMEDFDA UDIClass I (EU MDR)
Ref 374340
Identity
- Trade Name
- Beaver® FDA UDI
- Generic Name
- Scalpel handle, reusable FDA UDI
- Device Name
- OPHTHALMIC BLADE HANDLES, COLLETS & WRENCHES EUDAMEDHANLDE HEX 15.5CM LNG .5CM DIA (1/EA) FDA UDI
- Model / Reference
- 374340 EUDAMEDFDA UDI
- Description
- HANLDE HEX 15.5CM LNG .5CM DIA (1/EA) FDA UDI
Identifiers
- Catalog Number
- 374340 FDA UDI
- Primary DI / UDI-DI
- 30886158002186 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886158-PTD-204SeriesNSMN EUDAMED
- FDA Product Code
- GDZ FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Scalpel handle, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Northern Ireland 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ophthalmic Blade Handles, Collets & Wrenches by Beaver-Visitec International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0886158-PTD-204SeriesNSMN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beaver-Visitec International Inc
- EUDAMED SRN
- US-MF-000011461
- Authorised Representative
- BVI EU B.V. NL-AR-000032458
Sources (2)
- EUDAMED 5b572f31-662c-4272-8a39-9b42c7521a9d 61 fields · synced Jul 18, 2026
- FDA UDI e8da9ea2-7f39-4603-8fc6-0bfd64f4883a 36 fields · synced May 30, 2026