Catalog Number

ESW-8924

Brand Name

DISPOSABLE CSR WRAP

Version/Model Number

ESW-8924

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

K062100,K062100

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

fb43ce00-2fd7-49c4-bea2-42f8f96211c3

Public Version Date

January 04, 2021

Public Version Number

4

DI Record Publish Date

November 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-