Medline - DBD-GAUZE,BANDAGE LITE,3"X4.1YD,NS,LF - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: DBD-GAUZE,BANDAGE LITE,3"X4.1YD,NS,LF

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More Product Details

Catalog Number

PRM27493

Brand Name

Medline

Version/Model Number

PRM27493

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Device Record Status

Public Device Record Key

e7e5244d-9a5f-4fcc-a998-b90a700bd401

Public Version Date

January 27, 2021

Public Version Number

1

DI Record Publish Date

January 19, 2021

Additional Identifiers

Package DI Number

30193489005060

Quantity per Package

96

Contains DI Package

20193489005063

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