25ga Steerable Revolver

GUDID 00817489024621

Box of 10, 25ga Steerable Revolver

KATALYST SURGICAL LLC

Ophthalmic laser system beam guide
Primary Device ID00817489024621
NIH Device Record Keyc20228e1-4315-4715-a954-bdf9f13810af
Commercial Distribution StatusIn Commercial Distribution
Brand Name25ga Steerable Revolver
Version Model NumberRLP222-25
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
GS100817489024621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQBPhotocoagulator And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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