Catalog Number

59-0081-02

Brand Name

N/A

Version/Model Number

59-0081-02

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062510,K112671

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

09103694-a05a-43d4-8e10-9dd02cc56691

Public Version Date

July 08, 2021

Public Version Number

6

DI Record Publish Date

July 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-