SmartFrame - SMARTFrame XG MRI-Guided Trajectory Frame w/o Base - CLEARPOINT NEURO, INC.

Duns Number:959181160

Device Description: SMARTFrame XG MRI-Guided Trajectory Frame w/o Base

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More Product Details

Catalog Number

NGS-SF-04-11

Brand Name

SmartFrame

Version/Model Number

NGS-SF-04-11

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

HAW

Product Code Name

Neurological Stereotaxic Instrument

Device Record Status

Public Device Record Key

341f6d91-caa5-42ba-8519-bc7986d8a7f1

Public Version Date

June 27, 2022

Public Version Number

2

DI Record Publish Date

January 31, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLEARPOINT NEURO, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 138