Medline Industries, Inc. - KNEE PACK - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: KNEE PACK

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More Product Details

Catalog Number

DYNJ54733B

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJ54733B

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"

-

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

OJH

Product Code Name

Orthopedic tray

Device Record Status

Public Device Record Key

dd417707-07de-47aa-82c3-1ea62097c6f8

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

July 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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