Catalog Number

MDTZ1024986AX

Brand Name

Medline

Version/Model Number

MDTZ1024986AX

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"

Yes

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

-

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

d6ab1ac8-94f6-447f-86a5-01c0892e5b4b

Public Version Date

December 01, 2020

Public Version Number

1

DI Record Publish Date

November 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-