MEDLINE - INCISION & DRAINAGE TRAY - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: INCISION & DRAINAGE TRAY

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


More Product Details

Catalog Number

DYNDA1045

Brand Name

MEDLINE

Version/Model Number

DYNDA1045

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRP

Product Code Name

TRAY, SURGICAL

Device Record Status

Public Device Record Key

15d11962-e871-49e2-9d15-40243e1b7c80

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

January 01, 2022

Additional Identifiers

Package DI Number

40080196028963

Quantity per Package

28

Contains DI Package

10080196028962

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