Identity
- Trade Name
- Bausch + Lomb™ IOL Injector EUDAMEDBausch + Lomb FDA UDI
- Generic Name
- Manual intraocular lens injector, single-use FDA UDI
- Device Name
- Inserters EUDAMEDBausch + Lomb IOL Injector 10/B FDA UDI
- Model / Reference
- INJ100 EUDAMEDFDA UDI
- Description
- Bausch + Lomb IOL Injector 10/B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00757770505326 EUDAMEDFDA UDI
- Basic UDI-DI
- 0310119B1029ZN EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Q021111 OCULAR IMPLANT INSTRUMENTS, SINGLE-USE EUDAMED
- GMDN Term
- Manual intraocular lens injector, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Bausch + Lomb by Bausch & Lomb Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual intraocular lens injector, single-use.
- lioli™ IOL Delivery System — Ast Products, Inc. · Class I
- pioli™ IOL Delivery System — Ast Products, Inc. · Class I
- bioli™ IOL Delivery System — Ast Products, Inc. · Class I
- bioli™ IOL Delivery System — Ast Products, Inc. · Class I
- IOL Glide - Sheets — Hurricane Medical · Class I
- Surgical Glide — Hurricane Medical · Class I
- bioli™ IOL Delivery System — Ast Products, Inc. · Class I
- lioli™ IOL Delivery System — Ast Products, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
Sources (2)
- FDA UDI 254274f8-b337-407d-930c-ec26cf13426b 33 fields · synced Jul 27, 2026
- EUDAMED e5ed94f3-5f5b-4d00-85ee-69c4469670c5 61 fields · synced Jul 27, 2026