Handpieces and Cannulae M4504

GUDID 25056030403020

Act/Pass Backflush 25g

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID25056030403020
NIH Device Record Key80f7cd31-c56e-4593-92b8-e6a0e1215ffb
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandpieces and Cannulae
Version Model NumberM4504-02/5
Catalog NumberM4504
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
GS115056030403023 [Primary]
GS125056030403020 [Unit of Use]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


[25056030403020]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-28
Device Publish Date2024-10-18

Devices Manufactured by STERIMEDIX LIMITED

25056030403020 - Handpieces and Cannulae2024-10-28Act/Pass Backflush 25g
25056030403020 - Handpieces and Cannulae2024-10-28 Act/Pass Backflush 25g
15056030400534 - Formed Capsularhexis Cystotomes2024-10-28 25g x 5/8" Cyst Fmd
25056030400364 - Viscoelastic Cannulae2024-10-28 25g x 7/8" Viscoelastic
35056030400194 - Anterior Chamber Maintenance Cannulae2024-10-02 27g x 7/8" Transzonular
15056030400350 - Anterior Chamber Maintenance Cannulae2024-10-02 25g x 1" Ant Chamber
25056030402245 - Intradermal Cannulae2024-10-02 Intradermal Cannulae SILKANN CANNULA 18gx70mm
25056030403082 - Anterior Chamber Maintenance Cannulae2024-10-02 Anterior Chamber Maintenance Cannulae 27g x 7/8" Ant Chamber
15056030400428 - Refractive Cannulae2024-10-02 25g x 7/8" Lin Lasik

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