Ophthalmic Hook - STEVENS TENOTOMY HOOK - KATENA PRODUCTS, INC.

Duns Number:085668598

Device Description: STEVENS TENOTOMY HOOK

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More Product Details

Catalog Number

K3-6600

Brand Name

Ophthalmic Hook

Version/Model Number

K3-6600

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HNQ

Product Code Name

Hook, ophthalmic

Device Record Status

Public Device Record Key

d97cd2b6-7481-4559-8056-59eed2f2f945

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

September 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KATENA PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1518
2 A medical device with a moderate to high risk that requires special controls. 26
U Unclassified 63