Catalog Number

SW11611660-B

Brand Name

CareGUARD

Version/Model Number

SW11611660-B

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K213907,K213907

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

b8c1fd93-a164-469a-aaad-e4efd88cfc8a

Public Version Date

April 14, 2022

Public Version Number

1

DI Record Publish Date

April 06, 2022

Package DI Number

19332017001762

Quantity per Package

100

Contains DI Package

09332017001765

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton