20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex

GUDID 00817489023563

20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex

KATALYST SURGICAL LLC

Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use
Primary Device ID00817489023563
NIH Device Record Keya32e376f-abd4-4038-be23-4b476d5eeff7
Commercial Distribution StatusIn Commercial Distribution
Brand Name20ga Straight Illuminated Laser Probe, 19ga Needle Illumination, Iridex
Version Model NumberV6300-20AR
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
GS100817489023563 [Unit of Use]
GS110817489023560 [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 Date2020-12-03
Device Publish Date2020-11-25

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