Catalog Number

DSG.SMS.L4.M.BLU

Brand Name

StringKing

Version/Model Number

20225

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

7e147b27-7dd6-4060-ad00-1d8e8f2cdf47

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 17, 2021

Package DI Number

30195376202255

Quantity per Package

25

Contains DI Package

10195376202251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case