Catalog Number

UL7191-50

Brand Name

Blade lateral depth 50mm black

Version/Model Number

UL7191-50

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"

Yes

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

GZT

Product Code Name

RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Public Device Record Key

4c1c47ae-5c8b-4cc4-9819-4f3c2d5fe4c4

Public Version Date

November 19, 2018

Public Version Number

1

DI Record Publish Date

October 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-