Medline - WRAPPER,2PLY,45X45,WHITE BIAS, 2 DZ/CS - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: WRAPPER,2PLY,45X45,WHITE BIAS, 2 DZ/CS

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More Product Details

Catalog Number

MDT0132245

Brand Name

Medline

Version/Model Number

MDT0132245

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FRG

Product Code Name

Wrap, sterilization

Device Record Status

Public Device Record Key

a3496091-6c7c-4981-9041-4cf8e9265b42

Public Version Date

December 21, 2020

Public Version Number

1

DI Record Publish Date

December 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7