Catalog Number

276U6682

Brand Name

ComPel Single Wrap

Version/Model Number

276U6682

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K923408,K923408

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

0171f908-b47b-4690-bf1e-8f45dcd96c85

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

January 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-