Vitreoretinal Handpieces M4503

GUDID 25056030401484

Backflush/25g Soft Tip

STERIMEDIX LIMITED

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID25056030401484
NIH Device Record Key0e57c84f-8975-4675-96a9-bc9b06f6d397
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitreoretinal Handpieces
Version Model NumberM4503-02/5
Catalog NumberM4503
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 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
GS115056030401487 [Primary]
GS125056030401484 [Unit of Use]

FDA Product Code

MEDSterilant, Medical Devices

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


[25056030401484]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

Devices Manufactured by STERIMEDIX LIMITED

25056030400999 - Refractive Cannulae2025-04-02 25g x 7/8" Lin Lasik
25056030401019 - Vitreoretinal Cannulae2025-04-02 25g Silicone Brush
25056030401484 - Vitreoretinal Handpieces2025-04-02Backflush/25g Soft Tip
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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