Identity
- Trade Name
- AMO VITREPURE VITRECTOMY HANDPIECES AND FDA UDI
- Generic Name
- Vitrectomy system handpiece FDA UDI
- Device Name
- VITRECTOMY CUTTER, TUBING SET FDA UDI
- Model / Reference
- OPO39 FDA UDI
- Description
- VITRECTOMY CUTTER, TUBING SET FDA UDI
Identifiers
- Catalog Number
- OPO39 FDA UDI
- Primary DI / UDI-DI
- 05050474500204 FDA UDI
- FDA Product Code
- HQE FDA UDI
- GMDN Term
- Vitrectomy system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Vitrectomy system handpiece
Amo Vitrepure Vitrectomy Handpieces And by Johnson & Johnson Surgical Vision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
Sources (1)
- FDA UDI fd31bcd7-a38f-4e83-9f14-d48f624b6d7b 35 fields · synced Jun 9, 2026