Formed Irrigating Cystotomes M3001

GUDID 15056030400541

27g x 5/8" Endo Cyst

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID15056030400541
NIH Device Record Keyf87b2f9e-94d7-4e5e-8b2a-1aabd8be16ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameFormed Irrigating Cystotomes
Version Model NumberM3001-02/10
Catalog NumberM3001
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
GS115056030400541 [Unit of Use]
GS125056030400548 [Primary]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[15056030400541]

Ethylene Oxide


[15056030400541]

Ethylene Oxide


[15056030400541]

Ethylene Oxide


[15056030400541]

Ethylene Oxide


[15056030400541]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-17
Device Publish Date2024-12-09

Devices Manufactured by STERIMEDIX LIMITED

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25056030401019 - Vitreoretinal Cannulae2025-04-02 25g Silicone Brush
25056030401484 - Vitreoretinal Handpieces2025-04-02 Backflush/25g Soft Tip
35056030400996 - Vitreoretinal Cannulae2025-04-02 23g x 4mm VFI
35056030401009 - Vitreoretinal Cannulae2025-04-02 23g x 1 1/4" Asp Cann
55056030400969 - Hydrodissection Cannulae2025-02-25 30g x 7/8" Hydrodissector
15056030401746 - Bimanual I/A Systems2025-02-07 21g TW x 16m Bimanual
35056030400781 - Hydrodissection Cannulae2024-12-17 25g Tapered Hydro

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