Thera-P - PIVOTAL HEALTH SOLUTIONS, INC.

Duns Number:826316098

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More Product Details

Catalog Number

-

Brand Name

Thera-P

Version/Model Number

PT9020

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

INQ

Product Code Name

Table, Powered

Device Record Status

Public Device Record Key

47a5dbdd-c8d3-4782-bbbd-c36ff50ed1fa

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PIVOTAL HEALTH SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 86
2 A medical device with a moderate to high risk that requires special controls. 11