Device
Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.
Manufacturer
Medicel AG
Medicel AG
Model: LP604340
Catalog: LP604340
DI: 07630055213853
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
34071b0c-9759-4ed3-b7e4-3374d656d81b
Distribution Status:
In Commercial Distribution
DUNS Number:
487158263
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07630055213853
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47725
Name: Manual intraocular lens injector, single-use
Definition:
A hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of plastic materials. This is a single-use device.
FDA Product Codes
KYB
Lens, Guide, Intraocular
Premarket Submissions
Submission Number:
K070669
Supplement Number:
000