Formed Irrigating Cystotomes M3630

GUDID 05056030400698

30g x 5/8" Cyst Fmd

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID05056030400698
NIH Device Record Key6fd1d019-def7-48b9-a96b-e82a6d9de8c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameFormed Irrigating Cystotomes
Version Model Number3630-03/Y
Catalog NumberM3630
Company DUNS504799313
Company NameSTERIMEDIX LIMITED
Device Count1
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
GS105056030400698 [Primary]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05056030400698]

Ethylene Oxide


[05056030400698]

Ethylene Oxide


[05056030400698]

Ethylene Oxide


[05056030400698]

Ethylene Oxide


[05056030400698]

Ethylene Oxide


[05056030400698]

Ethylene Oxide


[05056030400698]

Ethylene Oxide


[05056030400698]

Ethylene Oxide


[05056030400698]

Ethylene Oxide


[05056030400698]

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 [Formed Irrigating Cystotomes]

1505603040054127g x 5/8" Endo Cyst
6505603040282327g x 5/8" Cyst Fmd
5505603040282627g x 5/8" Cyst Fmd
5505603040066225g x 5/8" Cyst Fmd
5056030400674025g Irrig Cyst Rev Fmd
5056030400629027g x 5/8" Cyst Ang
4505603040282927g x 5/8" Cyst Fmd
4505603040066525g x 5/8" Cyst Fmd
3505603040282227g x 5/8" Cyst Fmd
2505603040067825g x 5/8" Cyst Rev Fmd
3505603040066825g x 5/8" Cyst Fmd
2505603040058625g x 5/8" Cyst Fmd
2505603040282527g x 5/8" Cyst Fmd
2505603040066125g x 5/8" Cyst Fmd
0505603040282127g x 5/8" Irrig Cyst Fmd
0505603040069830g x 5/8" Cyst Fmd
0505603040066727g x 5/8" Irrig Cyst Fmd
0505603040065027g x 5/8" Cyst Short Cvd

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