Disposable Iris Retract K20-3890

GUDID 00841668125397

FLEXIBLE IRIS RETRACTORS 1 PK of 5

KATENA PRODUCTS, INC.

Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use Intraocular retractor, single-use
Primary Device ID00841668125397
NIH Device Record Key3f06475a-dd02-462f-81e8-ab55e912658e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Iris Retract
Version Model NumberK20-3890
Catalog NumberK20-3890
Company DUNS085668598
Company NameKATENA PRODUCTS, INC.
Device Count5
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841668114339 [Primary]
GS100841668125397 [Unit of Use]

FDA Product Code

HOCClip, iris retractor

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


[00841668125397]

Ethylene Oxide


Device Entry Metadata

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

On-Brand Devices [Disposable Iris Retract]

00841668125403FLEXIBLE IRIS RETRACTORS 5 PKS of 5
00841668125397FLEXIBLE IRIS RETRACTORS 1 PK of 5

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.