PROCARE - ARM SLING, CTN/POLY MED - DJO, LLC

Duns Number:081840873

Device Description: ARM SLING, CTN/POLY MED

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More Product Details

Catalog Number

-

Brand Name

PROCARE

Version/Model Number

155-79-84025

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

ILI

Product Code Name

SLING, ARM

Device Record Status

Public Device Record Key

0265ec73-16bf-4f72-876d-c215da86a405

Public Version Date

November 11, 2021

Public Version Number

1

DI Record Publish Date

November 03, 2021

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