FDA.reportPublic FDA data

ClearPoint

Primary DI
00850359007037
Brand
ClearPoint
Company
MRI INTERVENTIONS, INC.
Model
NGS-BM-05
Catalog number
NGS-BM-05
Device description
ClearPoint MRI Fiducial Markers
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative MriNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850359007037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850359007037008503590070378503590070370850359007037

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic device tracking system fiducial markerA non-sterile device intended to be used with an electromagnetic device tracking system to provide a physician with an external fixed reference point on the patient's body for the electromagnetic (EM) tracking of instruments inside the patient using pre-acquired images [e.g., computed tomography (CT) or magnetic resonance imaging (MRI)], or real-time image data and to join the imported CT and MRI images with real-time ultrasound (US). It typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an EM sensor for active registration. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-900-6833info@mriinterventions.com

Regulatory Flags#

DUNS number
959181160
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850359007042SmartFlowNGS-NC-01NGS-NC-012016-08-12
00850359007043SmartFlowNGS-NC-02NGS-NC-022016-08-12
00850359007044SmartFlowNGS-NC-03NGS-NC-032016-08-12
00850359007045SmartFlowNGS-NC-04NGS-NC-042016-08-12
00850359007046SmartFlowNGS-NC-05NGS-NC-052016-08-12
00850359007047SmartFlowNGS-NC-06NGS-NC-062016-08-12
00850359007048SmartflowNGS-NC-07NGS-NC-072016-08-12
00850359007049SmartFlowNGS-NC-08NGS-NC-082016-08-12
00850359007035SmartTipNGS-DB-01NGS-DB-012016-08-12
00850359007036SmartTipNGS-DB-45NGS-DB-452016-08-12
00850359007018ClearPointNGS-PD-02-LNGS-PD-02-L2016-08-12
00850359007019ClearPointNGS-PD-03NGS-PD-032016-08-12
00850359007020ClearPointNGS-PD-03-LNGS-PD-03-L2016-08-12
00850359007021ClearPointNGS-PD-04NGS-PD-042016-08-12
00850359007022ClearPointNGS-PD-05NGS-PD-052016-08-12
00850359007056ClearPointCP-EXT-21-01CP-EXT-21-012016-11-08
00850359007057ClearPointCP-EXT-22-01CP-EXT-22-012016-11-08
00850376007001ClearPointCP- HFF-111-01CP- HFF-111-012016-08-12
00850376007002ClearPointCP-HFF-112-01CP-HFF-112-012016-08-12
00850376007003ClearPointCP-HFF-122-01CP-HFF-122-012016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850376007703ClearPointClearpoint Neuro, Inc.ORR2022-10-06
00850376007857ClearPointClearpoint Neuro, Inc.ORR2022-10-06
00850359007003ClearPointClearpoint Neuro, Inc.ORR2022-03-09
00850376007758SmartFrameClearpoint Neuro, Inc.ORR2022-01-31
00850376007598SmartFrame Array Clearpoint Neuro, Inc.ORR2021-07-14
00850376007604ArrayClearpoint Neuro, Inc.ORR2021-07-14
00850376007628ArrayClearpoint Neuro, Inc.ORR2021-07-14
00850376007635ArrayClearpoint Neuro, Inc.ORR2021-07-14
00850359007744ClearPoint ArrayClearpoint Neuro, Inc.ORR2021-04-07
00850359007911ClearPoint Array WorkstationClearpoint Neuro, Inc.ORR2021-04-07
00850359007959SmartTipClearpoint Neuro, Inc.ORR2021-04-07
00850359007072SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007089SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007096SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007102SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007119SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007126SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007133SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007140SmartGridClearpoint Neuro, Inc.ORR2021-01-22
00850359007157ClearPointClearpoint Neuro, Inc.ORR2021-01-22
00850359007164SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007171SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007188ClearPointClearpoint Neuro, Inc.ORR2021-01-22
00850359007195ClearPointClearpoint Neuro, Inc.ORR2021-01-22
00850359007201ClearPointClearpoint Neuro, Inc.ORR2021-01-22
00850359007218ClearPointClearpoint Neuro, Inc.ORR2021-01-22
00850359007225ClearPointClearpoint Neuro, Inc.ORR2021-01-22
00850359007232SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007249SmartFrameClearpoint Neuro, Inc.ORR2021-01-22
00850359007256SmartFrameClearpoint Neuro, Inc.ORR2021-01-22