GemcisionTM Trapezoid, Super Sharp, Sharp Sides, 2.0/2.4mm Width/Box of 5

GUDID 00840096207118

GemcisionTM Trapezoid, Super Sharp, Sharp Sides, 2.0/2.4mm Width/Box of 5

KATALYST SURGICAL LLC

Ophthalmic knife, reusable
Primary Device ID00840096207118
NIH Device Record Keycafa4f98-c162-4681-ac17-10c6a14f410f
Commercial Distribution Discontinuation2022-12-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGemcisionTM Trapezoid, Super Sharp, Sharp Sides, 2.0/2.4mm Width/Box of 5
Version Model Number7900-T20/24b
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100840096207118 [Primary]

FDA Product Code

HNNKnife, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


[00840096207118]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-12-09
Device Publish Date2020-06-05

Devices Manufactured by KATALYST SURGICAL LLC

00840096207606 - DEX TIPS™ Universal Handle2026-01-12 DEX TIPS™ Universal Handle
00840096207613 - DEX TIPS™ Universal Slim Handle2026-01-12 DEX TIPS™ Universal Slim Handle
10817489025298 - Cyclophotocoagulation Probe, Quantel Connector2026-01-05
10817489025304 - Cyclophotocoagulation Probe, Iridex Connector2026-01-05
10817489024536 - Revolver Fiber2025-07-03
10817489024833 - Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 52025-07-03 Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 5
10817489024840 - Disposable Bipolar Focused Irrigating Forceps, 7", 1.0mm Straight Tips, Box of 52025-07-03 Disposable Bipolar Focused Irrigating Forceps, 7", 1.0mm Straight Tips, Box of 5
10817489024857 - Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 52025-07-03 Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.