Revolver Fiber

GUDID 10817489024536

KATALYST SURGICAL LLC

Ophthalmic laser system beam guide
Primary Device ID10817489024536
NIH Device Record Keyf4410119-f309-476d-9461-dc79c3ed86d5
Commercial Distribution Discontinuation2025-07-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRevolver Fiber
Version Model NumberV6600
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110817489024536 [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 Number2
Public Version Date2025-07-03
Device Publish Date2019-07-17

Devices Manufactured by KATALYST SURGICAL LLC

10817489024536 - Revolver Fiber2025-07-03
10817489024536 - Revolver Fiber2025-07-03
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