Catalog Number

SG127AC

Brand Name

SAFEGUARD®

Version/Model Number

10884450249038

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KCY

Product Code Name

TOURNIQUET, PNEUMATIC

Public Device Record Key

6eb65f3a-e564-4c30-9f60-9fec1444aa42

Public Version Date

March 16, 2022

Public Version Number

1

DI Record Publish Date

March 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-