microTargeting™ Verification Probe - 2.0 mm O.D. Verification Probe, 1xfor use with - FHC, INC.

Duns Number:108179458

Device Description: 2.0 mm O.D. Verification Probe, 1xfor use with microTargeting™ STar™ Drive and microTarget 2.0 mm O.D. Verification Probe, 1xfor use with microTargeting™ STar™ Drive and microTargeting™ Platform

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More Product Details

Catalog Number

66-IT-VP-03

Brand Name

microTargeting™ Verification Probe

Version/Model Number

66-IT-VP-03-00845

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

-

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

K092562

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

0fa8a0b4-7d22-411b-97dd-81a09d577178

Public Version Date

November 05, 2021

Public Version Number

1

DI Record Publish Date

October 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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