Bimanual Cannulae and Hand Pieces M5521

GUDID 15056030401715

21g x 5/8" Bimanual Irr

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID15056030401715
NIH Device Record Keyeb3587f3-23a1-46d5-b71e-e5532b4d6545
Commercial Distribution StatusIn Commercial Distribution
Brand NameBimanual Cannulae and Hand Pieces
Version Model NumberM5521-02/5
Catalog NumberM5521
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
GS115056030401715 [Unit of Use]
GS125056030401712 [Primary]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[15056030401715]

Ethylene Oxide


[15056030401715]

Ethylene Oxide


[15056030401715]

Ethylene Oxide


[15056030401715]

Ethylene Oxide


[15056030401715]

Ethylene Oxide


[15056030401715]

Ethylene Oxide


[15056030401715]

Ethylene Oxide


[15056030401715]

Ethylene Oxide


[15056030401715]

Ethylene Oxide


[15056030401715]

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 [Bimanual Cannulae and Hand Pieces]

2505603040166821g x 5/8" Bimanual Irr
1505603040171521g x 5/8" Bimanual Irr
3505603040168923g x 5/8" Bimanual Asp
4505603040165523g x 5/8" Bimanual Irr
1505603040161621g x 5/8" Bimanual Irr
1505603040158621g x 5/8 Bimanual Irr
3505603040167221g x 7/8" Bimanual Asp

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