Refractive Cannulae M2801-02/100

GUDID 35056030400422

25g x 7/8" Lin Lasik

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID35056030400422
NIH Device Record Keyf7d97a0f-7bcf-46a3-b56d-0bbfb3c66ef3
Commercial Distribution StatusIn Commercial Distribution
Brand NameRefractive Cannulae
Version Model NumberM2801
Catalog NumberM2801-02/100
Company DUNS504799313
Company NameSTERIMEDIX LIMITED
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115056030400428 [Primary]
GS135056030400422 [Unit of Use]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


[35056030400422]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-03
Device Publish Date2024-08-26

On-Brand Devices [Refractive Cannulae]

3505603040042225g x 7/8" Lin Lasik
1505603040042825g x 7/8" Lin Lasik

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.