Catalog Number

124675B

Brand Name

NOVO Health Services, LLC

Version/Model Number

124675

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 20, 2022

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

K102783

Product Code

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

9b43f629-c718-4ecb-9e51-51c4ae253b72

Public Version Date

October 21, 2022

Public Version Number

2

DI Record Publish Date

March 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-