Backflush Aspiration Handpieces M4489A

GUDID 25056030401354

Active / Passive

STERIMEDIX LIMITED

Ophthalmic surgical irrigation/infusion/aspiration handle, single-use
Primary Device ID25056030401354
NIH Device Record Key375070c9-13a3-470c-a8a7-e6764ffbcb55
Commercial Distribution StatusIn Commercial Distribution
Brand NameBackflush Aspiration Handpieces
Version Model NumberM4489A-02/5
Catalog NumberM4489A
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 Datetrue
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
GS115056030401357 [Primary]
GS125056030401354 [Unit of Use]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[25056030401354]

Ethylene Oxide


[25056030401354]

Ethylene Oxide


[25056030401354]

Ethylene Oxide


[25056030401354]

Ethylene Oxide


[25056030401354]

Ethylene Oxide


[25056030401354]

Ethylene Oxide


[25056030401354]

Ethylene Oxide


[25056030401354]

Ethylene Oxide


[25056030401354]

Ethylene Oxide


[25056030401354]

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 [Backflush Aspiration Handpieces]

25056030401354Active / Passive
45056030401341Backflush Handle

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