Identity
- Trade Name
- NAVIJECT SUB2-1P INJECTOR SET FDA UDI
- Generic Name
- Manual intraocular lens injector, single-use FDA UDI
- Device Name
- Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures. FDA UDI
- Model / Reference
- LP604430W FDA UDI
- Description
- Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures. FDA UDI
Identifiers
- Catalog Number
- LP604430W FDA UDI
- Primary DI / UDI-DI
- 07630055222107 FDA UDI
- 510(k) Number
- K092023 FDA UDI
- FDA Product Code
- MSS FDA UDI
- GMDN Term
- Manual intraocular lens injector, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4300 FDA UDI
- Commercial Distribution
- Not 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
Naviject Sub2-1p Injector Set by Medicel AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medicel AG
Sources (1)
- FDA UDI f85968d2-60fd-4c08-bf6e-79eedbb16eb1 37 fields · synced Jun 8, 2026