microTargeting™ STar™ Array Insertion Tube Extractor - microTargeting STar Array Insertion Tube - FHC, INC.

Duns Number:108179458

Device Description: microTargeting STar Array Insertion Tube Extractor, 5x, Sterile, for use the STar Array In microTargeting STar Array Insertion Tube Extractor, 5x, Sterile, for use the STar Array Insertion Tubes

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

70-CN-ET

Brand Name

microTargeting™ STar™ Array Insertion Tube Extractor

Version/Model Number

70-CN-ET-00236

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

Yes

Prescription Use (Rx)

Yes

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

HAO

Product Code Name

INSTRUMENT, SURGICAL, NON-POWERED

Device Record Status

Public Device Record Key

292bd06e-d159-4249-972b-9b94849f3ce4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

10873263002367

Quantity per Package

5

Contains DI Package

00873263002360

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK/5

"FHC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 476