Cannulae Olive Tipped Cannulae M8621

GUDID 15056030402323

23g x 1" Olive Tipped Pol

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID15056030402323
NIH Device Record Keyce53b50b-469b-4db4-9fdf-7e84412f2b7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulae Olive Tipped Cannulae
Version Model NumberM8621-02/10
Catalog NumberM8621
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
GS115056030402323 [Unit of Use]
GS125056030402320 [Primary]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[15056030402323]

Ethylene Oxide


[15056030402323]

Ethylene Oxide


[15056030402323]

Ethylene Oxide


[15056030402323]

Ethylene Oxide


[15056030402323]

Ethylene Oxide


[15056030402323]

Ethylene Oxide


[15056030402323]

Ethylene Oxide


[15056030402323]

Ethylene Oxide


[15056030402323]

Ethylene Oxide


[15056030402323]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-15
Device Publish Date2024-10-07

Devices Manufactured by STERIMEDIX LIMITED

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25056030401804 - Bimanual I/A Systems2025-09-01 Bimanual I/A Set
25056030400999 - Refractive Cannulae2025-04-02 25g x 7/8" Lin Lasik
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

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