HONAN BALLOON WITH PRESS VALVE K 9-8410

GUDID 00841668112137

KATENA PRODUCTS, INC.

Intraocular pressure-reducing system
Primary Device ID00841668112137
NIH Device Record Keyd46c77ef-4b85-420c-b040-acc45c83ab64
Commercial Distribution StatusIn Commercial Distribution
Brand NameHONAN BALLOON WITH PRESS VALVE
Version Model NumberK 9-8410
Catalog NumberK 9-8410
Company DUNS085668598
Company NameKATENA PRODUCTS, INC.
Device Count1
DM Exempttrue
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 Latextrue
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
GS100841668112137 [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

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