20ga Straight Laser Probe, DORC

GUDID 00817489020043

Box of 10, 20ga Straight Laser Probe, DORC

KATALYST SURGICAL LLC

Ophthalmic fibreoptic light instrument, single-use
Primary Device ID00817489020043
NIH Device Record Key86f2f5ab-49b8-4d53-8f4c-7124bf86f199
Commercial Distribution StatusIn Commercial Distribution
Brand Name20ga Straight Laser Probe, DORC
Version Model NumberV6000-20J
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
Device Count1
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
GS100817489020043 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2016-08-04

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