Catalog Number

7320-H-27-80

Brand Name

Black Belt Two-Level Blunt Blade

Version/Model Number

7320-H-27-80

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K935529,K935529

Product Code

GZT

Product Code Name

Retractor, Self-Retaining, For Neurosurgery

Public Device Record Key

ab3909b8-24b1-4cbd-bf5e-978a3436f7bf

Public Version Date

June 14, 2021

Public Version Number

1

DI Record Publish Date

June 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-