HONAN BALLOON HEADBAND (NO LATEX) K 9-8412

GUDID 00841668112151

KATENA PRODUCTS, INC.

Intraocular pressure-reducing system
Primary Device ID00841668112151
NIH Device Record Keye8c3a956-b621-4616-8a83-a5f2392c461b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHONAN BALLOON HEADBAND (NO LATEX)
Version Model NumberK 9-8412
Catalog NumberK 9-8412
Company DUNS085668598
Company NameKATENA PRODUCTS, INC.
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 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

Customer Support Contacts

Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com
Phone(973) 989-1600
Emailglobe@katena.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841668112151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCCApplicator, Ocular Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

Devices Manufactured by KATENA PRODUCTS, INC.

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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

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