PERFORMANCE HEALTH - Rolyan Shoulder Immobilizer, Small - Asp Global, LLC

Duns Number:080361159

Device Description: Rolyan Shoulder Immobilizer, Small

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More Product Details

Catalog Number

-

Brand Name

PERFORMANCE HEALTH

Version/Model Number

A545801

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)

Yes

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

NOD

Product Code Name

Board, Arm (With Cover), Non-Sterile

Device Record Status

Public Device Record Key

9812d84c-530e-4c59-af00-2020b5a7c3da

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASP GLOBAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1046
2 A medical device with a moderate to high risk that requires special controls. 23
U Unclassified 2