Bimanual I/A Systems M5531

GUDID 15056030401746

21g TW x 16m Bimanual

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID15056030401746
NIH Device Record Keyce460530-802d-46d8-a075-78cf574e003e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBimanual I/A Systems
Version Model NumberM5531-02/5
Catalog NumberM5531
Company DUNS504799313
Company NameSTERIMEDIX LIMITED
Device Count5
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
GS115056030401746 [Unit of Use]
GS125056030401743 [Primary]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[15056030401746]

Ethylene Oxide


[15056030401746]

Ethylene Oxide


[15056030401746]

Ethylene Oxide


[15056030401746]

Ethylene Oxide


[15056030401746]

Ethylene Oxide


[15056030401746]

Ethylene Oxide


[15056030401746]

Ethylene Oxide


[15056030401746]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-07
Device Publish Date2025-01-30

On-Brand Devices [Bimanual I/A Systems]

3505603040174021g TW x 16m Bimanual
1505603040174621g TW x 16m Bimanual

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