Identity
- Trade Name
- I² Kit for intraocular injection FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Intraocular injection kit - standard set (speculum, marker, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe) FDA UDI
- Model / Reference
- VS0510 FDA UDI
- Description
- Intraocular injection kit - standard set (speculum, marker, 18ga needle, 27ga needle, 30ga needle, gloves, swabs, 1.0 ml syringe) FDA UDI
Identifiers
- Catalog Number
- VS0510 FDA UDI
- Primary DI / UDI-DI
- B384VS05101 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
I² Kit for intraocular injection by Vortex Surgical, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Vortex Surgical, Inc.
Sources (1)
- FDA UDI d9a09db3-45fa-4020-a352-918e4190f821 35 fields · synced Jun 6, 2026