Irrigating Cystotome - Reverse 3125

GUDID 08134650131257

Creates opening into anterior capsule during cataract treatment.

HURRICANE MEDICAL INC

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID08134650131257
NIH Device Record Key5e8365d3-1f0f-4d31-997f-049b5299fb03
Commercial Distribution StatusIn Commercial Distribution
Brand NameIrrigating Cystotome - Reverse
Version Model Number3125
Catalog Number3125
Company DUNS093377724
Company NameHURRICANE MEDICAL INC
Device Count1
DM Exempttrue
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 Dimensions

Length16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108134650131257 [Primary]

FDA Product Code

HNYCystotome

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08134650131257]

Ethylene Oxide;Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-30
Device Publish Date2020-01-22

On-Brand Devices [Irrigating Cystotome - Reverse]

08134650131257Creates opening into anterior capsule during cataract treatment.
00813465010466Creates opening into anterior capsule during cataract treatment.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.