Catalog Number

SDV10

Brand Name

Steriking®

Version/Model Number

SDV10

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

K210810,K210810,K210810

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

dfdc0667-0b50-41c0-88cb-9f9e400b1161

Public Version Date

June 16, 2022

Public Version Number

1

DI Record Publish Date

June 08, 2022

Package DI Number

06438263665584

Quantity per Package

4

Contains DI Package

06438263665577

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-