Pinestar Technology Inc - AP PA Ault Head Immobilizer - PINESTAR TECHNOLOGY, INC.

Duns Number:037933645

Device Description: AP PA Ault Head Immobilizer

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More Product Details

Catalog Number

-

Brand Name

Pinestar Technology Inc

Version/Model Number

PTI-408FPC

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

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

60088918-5420-48dc-b2bc-4c8fa752e8bc

Public Version Date

August 27, 2020

Public Version Number

1

DI Record Publish Date

August 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PINESTAR TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 47