Ophthalmic Scissors - IRIS SCISSORS SMALL CURVED - KATENA PRODUCTS, INC.

Duns Number:085668598

Device Description: IRIS SCISSORS SMALL CURVED

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More Product Details

Catalog Number

K4-4410

Brand Name

Ophthalmic Scissors

Version/Model Number

K4-4410

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

HNF

Product Code Name

SCISSORS, OPHTHALMIC

Device Record Status

Public Device Record Key

3115a4c5-6e6c-45b7-ab04-7504d8cbbd71

Public Version Date

September 22, 2020

Public Version Number

1

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