Black Belt Two-Level Ti Blunt Blade - Black Belt Two-Level Titanium Blunt Blade 27 x - KOROS U.S.A., INC.

Duns Number:007928633

Device Description: Black Belt Two-Level Titanium Blunt Blade 27 x 40mm

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More Product Details

Catalog Number

7328-40T

Brand Name

Black Belt Two-Level Ti Blunt Blade

Version/Model Number

7328-40T

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

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

c4a94d13-372b-4491-b0e6-a5d7be85ed99

Public Version Date

October 11, 2021

Public Version Number

1

DI Record Publish Date

October 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOROS U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2597
2 A medical device with a moderate to high risk that requires special controls. 416