Viscoelastic Cannulae M3917

GUDID 45056030400894

27g x 7/8" Viscoelastic

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID45056030400894
NIH Device Record Keyecde22d4-813e-4db1-983e-eb1f5a2754a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameViscoelastic Cannulae
Version Model NumberM3917-02/10
Catalog NumberM3917
Company DUNS504799313
Company NameSTERIMEDIX LIMITED
Device Count10
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
GS115056030400893 [Primary]
GS145056030400894 [Unit of Use]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[45056030400894]

Ethylene Oxide


[45056030400894]

Ethylene Oxide


[45056030400894]

Ethylene Oxide


[45056030400894]

Ethylene Oxide


[45056030400894]

Ethylene Oxide


[45056030400894]

Ethylene Oxide


[45056030400894]

Ethylene Oxide


[45056030400894]

Ethylene Oxide


[45056030400894]

Ethylene Oxide


[45056030400894]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-15
Device Publish Date2024-10-07

On-Brand Devices [Viscoelastic Cannulae]

2505603040036425g x 7/8" Viscoelastic
3505603040095827g X 7/8" Viscoelastic
2505603040093727g x 7/8" Viscoelastic
1505603040095427g x 7/8" Viscoelastic
4505603040089427g x 7/8" Viscoelastic

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.