Medline - DRAPE,22X22,1"FENE W/5X5 REN,KMG - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: DRAPE,22X22,1"FENE W/5X5 REN,KMG

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More Product Details

Catalog Number

MDTL1410275Q

Brand Name

Medline

Version/Model Number

MDTL1410275Q

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

KKX

Product Code Name

Drape, surgical

Device Record Status

Public Device Record Key

502b0e4b-048d-4f71-931b-e411943b0fb2

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

30888277418541

Quantity per Package

2

Contains DI Package

20888277418544

Package Discontinue Date

-

Package Status

In Commercial Distribution

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