25ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex

GUDID 00817489023662

25ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex

KATALYST SURGICAL LLC

Ophthalmic fibreoptic light instrument, single-use
Primary Device ID00817489023662
NIH Device Record Key66df9a36-0898-4ef6-8369-821531a85f2e
Commercial Distribution StatusIn Commercial Distribution
Brand Name25ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex
Version Model NumberV6300-25AR
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817489023662 [Unit of Use]
GS110817489023669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-07
Device Publish Date2020-11-27

Devices Manufactured by KATALYST SURGICAL LLC

00840096206128 - 23ga ISOCLEAN™ Capsulorhexis Forceps, Blunt Tips, Gold2025-04-04 23ga ISOCLEAN™ Capsulorhexis Forceps, Blunt Tips, Gold
00840096206340 - 23ga ISOCLEAN™ Serrated Forceps, Curved Shaft, Gold2025-04-04 23ga ISOCLEAN™ Serrated Forceps, Curved Shaft, Gold
00840096206357 - 23ga ISOCLEAN™ Serrated Forceps, Straight Shaft, Gold2025-04-04 23ga ISOCLEAN™ Serrated Forceps, Straight Shaft, Gold
00840096208344 - ISOCLEAN™ Johnston Extractor Forceps2025-04-04 ISOCLEAN™ Johnston Extractor Forceps
00840096208443 - 23ga iQ™ Capsulorhexis Forceps, Blunt, Gold2025-04-04 23ga iQ™ Capsulorhexis Forceps, Blunt, Gold
00840096208450 - 23ga iQ™ MICS Capsulorhexis Forceps, Gold2025-04-04 23ga iQ™ MICS Capsulorhexis Forceps, Gold
00840096209525 - 23ga iQ™ Pyramid Tip Forceps2025-04-04 23ga iQ™ Pyramid Tip Forceps
00840096209532 - 25ga iQ™ Pyramid Tip Forceps, Gold2025-04-04 25ga iQ™ Pyramid Tip Forceps, Gold

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.