Medline Industries, Inc. - KIT TISSEEL APP 16GA X 3.75 - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: KIT TISSEEL APP 16GA X 3.75

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

DYNDA2944

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNDA2944

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K981386,K981386

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

9d2e00cd-fb2c-4259-bd87-b5f172693cc6

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

May 08, 2022

Additional Identifiers

Package DI Number

40195327155569

Quantity per Package

200

Contains DI Package

10195327155568

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