Catalog Number

-

Brand Name

SUTUREGARD Intraoperative Skin Relaxation Device

Version/Model Number

1

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

KGS

Product Code Name

Retention Device, Suture

Public Device Record Key

a7ecfc5c-22da-4717-a5c3-6b960c9f2526

Public Version Date

November 26, 2021

Public Version Number

1

DI Record Publish Date

November 18, 2021

Package DI Number

10860007834216

Quantity per Package

12

Contains DI Package

00860007834219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box