Identity
- Trade Name
- Cystalsert Delivery System FDA UDI
- Generic Name
- Manual intraocular lens injector, single-use FDA UDI
- Device Name
- Inserter - Lens Delivery System FDA UDI
- Model / Reference
- CI-28 FDA UDI
- Description
- Inserter - Lens Delivery System FDA UDI
Identifiers
- Catalog Number
- CI-28 FDA UDI
- Primary DI / UDI-DI
- 00757770488964 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
- 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: Manual intraocular lens injector, single-use
Cystalsert Delivery System by Bausch & Lomb Incorporated — 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
- Bausch & Lomb Incorporated
Sources (1)
- FDA UDI 42d864fb-cf04-4d2d-838c-e6630210f876 34 fields · synced Jun 8, 2026