MEDLINE INDUSTRIES, INC. - CAP,SURGEON,MULTI LAYER,TIE BACK,BLUE - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: CAP,SURGEON,MULTI LAYER,TIE BACK,BLUE

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More Product Details

Catalog Number

NON28626

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

NON28626

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

FYF

Product Code Name

CAP, SURGICAL

Device Record Status

Public Device Record Key

61511ada-6e10-40f6-896b-28334eb867b3

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

May 20, 2021

Additional Identifiers

Package DI Number

40080196293552

Quantity per Package

500

Contains DI Package

30080196293555

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON

"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