Refractive Cannulae M2804

GUDID 25056030400449

25g x 7/8" Lasik Irrig

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID25056030400449
NIH Device Record Key2dac2061-c0bb-4aa3-90e2-9d7dc70f2452
Commercial Distribution StatusIn Commercial Distribution
Brand NameRefractive Cannulae
Version Model NumberM2804-02/10
Catalog NumberM2804
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
GS125056030400449 [Unit of Use]
GS135056030400446 [Primary]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[25056030400449]

Ethylene Oxide


[25056030400449]

Ethylene Oxide


[25056030400449]

Ethylene Oxide


[25056030400449]

Ethylene Oxide


[25056030400449]

Ethylene Oxide


[25056030400449]

Ethylene Oxide


[25056030400449]

Ethylene Oxide


[25056030400449]

Ethylene Oxide


[25056030400449]

Ethylene Oxide


[25056030400449]

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 [Refractive Cannulae]

3505603040042225g x 7/8" Lin Lasik
1505603040042825g x 7/8" Lin Lasik
2505603040099925g x 7/8" Lin Lasik
2505603040044925g x 7/8" Lasik Irrig
4505603040087023g x 22mm LASIK Irr
3505603040048426g x 7/8" LASIK Slade
4505603040043625g x 1 1/8" Buratto Lasi

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