Catalog Number

SH-130

Brand Name

LiNA Skin Hook™

Version/Model Number

SH-130

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

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

GAD

Product Code Name

Retractor

Public Device Record Key

54909591-a02f-44ba-b8e7-6e1f7f91f8ff

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

November 03, 2020

Package DI Number

05708265011988

Quantity per Package

5

Contains DI Package

05708265011971

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box