Identity
- Trade Name
- 20 GA ULTRAVIT FDA UDI
- Generic Name
- Vitrectomy system handpiece FDA UDI
- Device Name
- 20 GA/5000 CPM; Vitrectomy Pak FDA UDI
- Model / Reference
- 8065751020 FDA UDI
- Description
- 20 GA/5000 CPM; Vitrectomy Pak FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380657510207 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Vitrectomy system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 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
20 Ga Ultravit by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vitrectomy system handpiece.
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- INTRECTOR® — INSIGHT INSTRUMENTS, INC. · Class II
- DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI — Johnson & Johnson Surgical Vision, Inc. · Class II
- AMO VITREPURE VITRECTOMY HANDPIECES AND — Johnson & Johnson Surgical Vision, Inc. · Class II
- AMO LIMBAL NEEDLE ASSEMBLY — Johnson & Johnson Surgical Vision, Inc. · Class II
- AMO TAC VITRECTOMY HANDPIECE — Johnson & Johnson Surgical Vision, Inc. · Class II
- DISPOSABLE 25GA VITRECTOMY CUTTER — Johnson & Johnson Surgical Vision, Inc. · Class II
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
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI e6411715-c00c-4e36-8b35-f1afbc669170 35 fields · synced May 30, 2026