Medline Industries, Inc. - FOAM BUMP, LARGE - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: FOAM BUMP, LARGE

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More Product Details

Catalog Number

DYNJBUMP01

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJBUMP01

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

-

Product Code Details

Product Code

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Record Status

Public Device Record Key

664d1c7a-a2bb-4b8d-9020-0b682173270b

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

August 28, 2018

Additional Identifiers

Package DI Number

40888277582461

Quantity per Package

28

Contains DI Package

10888277582460

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