Pinestar Technology Inc - Imaging Head Support - PINESTAR TECHNOLOGY, INC.

Duns Number:037933645

Device Description: Imaging Head Support

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More Product Details

Catalog Number

-

Brand Name

Pinestar Technology Inc

Version/Model Number

DAT-HH

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

IWY

Product Code Name

Holder, Head, Radiographic

Device Record Status

Public Device Record Key

3d33fe11-bdd5-4e34-84e7-b9651a191735

Public Version Date

July 31, 2020

Public Version Number

1

DI Record Publish Date

July 23, 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