Catalog Number

129077

Brand Name

SRI Healthcare

Version/Model Number

129077

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

K102864

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

44bbca36-4d1e-4940-bb6e-1e57fc0ab73f

Public Version Date

July 07, 2021

Public Version Number

1

DI Record Publish Date

June 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-