Primary Lens Set, 28D, 90D, 4 Mirror

GUDID 00841668144275

KATENA PRODUCTS, INC.

Ophthalmic diagnostic condensing lens
Primary Device ID00841668144275
NIH Device Record Keyad0732cd-6c69-46aa-ab13-cc8f03b13140
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimary Lens Set, 28D, 90D, 4 Mirror
Version Model NumberK31-3005
Company DUNS085668598
Company NameKATENA PRODUCTS, INC.
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
GS100841668144275 [Primary]

FDA Product Code

HJLLens, condensing, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-19
Device Publish Date2024-04-11

Devices Manufactured by KATENA PRODUCTS, INC.

00841668145906 - BLINK2026-03-31 Anterior Chamber Cannula - 30G30G x 7/8", (0.3 x 22mm), 4mm Tip
00841668145913 - BLINK2026-03-31 Anterior Chamber Cannula - 27G27G x 7/8", (0.4 x 22mm), 4mm Tip
00841668145920 - BLINK2026-03-31 Anterior Chamber Cannula - 21G21G x 7/8", (0.81 x 22mm), 4mm Tip
00841668145937 - BLINK2026-03-31 Anterior Chamber Cannula - 27G27G x 7/8", (0.4 x 22mm), 6mm Tip
00841668145944 - BLINK2026-03-31 Anterior Chamber Cannula - 30G30G x 7/8", (0.3 x 22mm) 6mm Tip
00841668145951 - BLINK2026-03-31 Hydrodissector Cannula - 30G30G x 7/8", (0.3 x 22mm), Angled
00841668145968 - BLINK2026-03-31 Irrigating Cystotome - 23G23G x 5/8", (0.64 x 16mm), Formed
00841668145982 - BLINK2026-03-31 Irrigating Cystotome - 25G25G x 5/8", (0.5 x 16mm), Formed

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