Irrigating Cystotome - Pearce 3025

GUDID 08134650130250

Creates opening into anterior capsule during cataract treatment.

HURRICANE MEDICAL INC

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Primary Device ID08134650130250
NIH Device Record Key53e7f154-42f0-4d48-8479-a23fe3c8ff5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameIrrigating Cystotome - Pearce
Version Model Number3025
Catalog Number3025
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

Needle Gauge25 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS108134650130250 [Primary]

FDA Product Code

HNYCystotome

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08134650130250]

Radiation Sterilization;Ethylene Oxide


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 - Pearce]

08134650130250Creates opening into anterior capsule during cataract treatment.
00813465010435Creates opening into anterior capsule during cataract treatment.

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