DONJOY PERFORMANCE - DJP 2MM KNEE SLEEVE, CAMO, SMALL - DJO, LLC

Duns Number:081840873

Device Description: DJP 2MM KNEE SLEEVE, CAMO, SMALL

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More Product Details

Catalog Number

-

Brand Name

DONJOY PERFORMANCE

Version/Model Number

DP151KS02-CAM-S

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

-

Prescription Use (Rx)

-

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

ITQ

Product Code Name

JOINT, KNEE, EXTERNAL BRACE

Device Record Status

Public Device Record Key

e0f7467e-4e1d-460d-a3e9-d42a26fb26fd

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DJO, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 784
2 A medical device with a moderate to high risk that requires special controls. 1030
3 A medical device with high risk that requires premarket approval 8