Blade Scalpel - SCLEROTOME BLADE #57 (BX/5) - KATENA PRODUCTS, INC.

Duns Number:085668598

Device Description: SCLEROTOME BLADE #57 (BX/5)

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More Product Details

Catalog Number

K20-2457

Brand Name

Blade Scalpel

Version/Model Number

K20-2457

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

Yes

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

GES

Product Code Name

BLADE, SCALPEL

Device Record Status

Public Device Record Key

969415ef-8a5b-409d-9b47-199c271ad242

Public Version Date

January 22, 2021

Public Version Number

3

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