Medline - TUBING TYVK 6" X 100' ROLL - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: TUBING TYVK 6" X 100' ROLL

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More Product Details

Catalog Number

MPP100680N

Brand Name

Medline

Version/Model Number

MPP100680N

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

0be24394-4506-4cf3-9ce9-19e1c833071d

Public Version Date

September 05, 2022

Public Version Number

2

DI Record Publish Date

November 11, 2021

Additional Identifiers

Package DI Number

40080196752776

Quantity per Package

8

Contains DI Package

10080196752775

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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