Scleral Marker K1-7790

GUDID 00841668100875

GASS SCLERAL MARKER

KATENA PRODUCTS, INC.

Scleral marker, reusable
Primary Device ID00841668100875
NIH Device Record Key27f0351b-ee4a-4426-97ce-48417b029a77
Commercial Distribution StatusIn Commercial Distribution
Brand NameScleral Marker
Version Model NumberK1-7790
Catalog NumberK1-7790
Company DUNS085668598
Company NameKATENA PRODUCTS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinfo@katena.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com
Phone+1(973)989-1600
Emailinquiries.corzaeye@corza.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841668100875 [Primary]

FDA Product Code

HMQMarker, sclera

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-22
Device Publish Date2020-09-14

Devices Manufactured by KATENA PRODUCTS, INC.

00841668144268 - Primary Lens Set, 28D, 90D, 3 Mirror2024-04-19
00841668144275 - Primary Lens Set, 28D, 90D, 4 Mirror2024-04-19
00841668137406 - VRTIS KUSAKA 25 GAUGE VERTICAL SCISSORS2023-10-18 VRTIS KUSAKA 25 GAUGE VERTICAL SCISSORS
00841668137413 - VRTIS SATO HORIZONTAL 23 GAUGE SCISSORS2023-10-18 VRTIS SATO HORIZONTAL 23 GAUGE SCISSORS
10841668114848 - Color Bar Schirmer Tear Test2023-07-14 (50 Pouches)
10841668143312 - ABS CLEAR CORNEA ANGLED BLADE 2MM 6/BOX2023-06-02 ABS CLEAR CORNEA ANGLED BLADE 2MM 6/BOX
00841668123966 - Ophthalmic Knife2022-12-15 NANO Engineered Diamond Knife 45 degrees
00841668123980 - Ophthalmic Knife2022-12-15 NANO Engineered Dia Knife 1mm spear ang

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.