Vitreoretinal Cannulae M4478

GUDID 35056030401009

23g x 1 1/4" Asp Cann

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID35056030401009
NIH Device Record Key301e483f-1b29-4477-b519-080de2dcde46
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitreoretinal Cannulae
Version Model NumberM4478-02/10
Catalog NumberM4478
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
GS125056030401316 [Primary]
GS135056030401009 [Unit of Use]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


[35056030401009]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

On-Brand Devices [Vitreoretinal Cannulae]

3505603040100923g x 1 1/4" Asp Cann
3505603040099623g x 4mm VFI
2505603040101925g Silicone Brush

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