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SpinVision Sterile Equipment Cover
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 891BG
Identity
- Trade Name
- SpinVision Sterile Equipment Cover EUDAMEDFDA UDI
- Generic Name
- Medical equipment handle cover, single-use FDA UDI
- Device Name
- Sterile Drapes EUDAMEDFor Rotational IVUS FDA UDI
- Model / Reference
- 891BG EUDAMEDFDA UDI
- Description
- For Rotational IVUS FDA UDI
Identifiers
- Catalog Number
- 891BG FDA UDI
- Primary DI / UDI-DI
- 10845225012684 EUDAMEDFDA UDI00845225012687 EUDAMED
- Basic UDI-DI
- B-10845225012684 EUDAMEDB-00845225012687 EUDAMED
- 510(k) Number
- K052395 FDA UDI
- FDA Product Code
- KKX FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Medical equipment handle cover, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
SpinVision Sterile Equipment Cover by Volcano Corporation — Class I — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052395 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-10845225012684 | Class I | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (4)
- EUDAMED 615408f0-95d4-468f-9610-ab41abf99987 61 fields · synced Jul 9, 2026
- EUDAMED 4e6e1a45-5bbc-41bb-b1ed-4f8175256415 61 fields · synced May 19, 2026
- FDA UDI 1d5ea6f6-9618-47a4-992b-363b312adb36 37 fields · synced May 30, 2026
- FDA 510(k) K052395 1 fields · synced May 18, 2026