Catalog Number

-

Brand Name

"maxill steri-sox Self Sealing Sterilization Pouches 7.5" x 13"

Version/Model Number

60145

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102158,K102158

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

468913fb-0b27-4168-9cae-39a7e5128cb7

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

October 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-