FDA.reportPublic FDA data

ClearPoint

Primary DI
00850359007057
Brand
ClearPoint
Company
MRI INTERVENTIONS, INC.
Model
CP-EXT-22-01
Catalog number
CP-EXT-22-01
Device description
ClearPoint SMS 3T Flex Coil IMRIS Interface
Published
2016-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111802000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111802000SV BRAIN ARRAY, SIEMENS 3TMri Interventions, Inc.2011-09-08MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850359007057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850359007057008503590070578503590070570850359007057

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency MRI system coilA radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This GMDN code includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.

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
true
Manufacturing date on label
false
Expiration date on label
false
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
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
00850376007004ClearPointCP- HFF-211-01CP- HFF-211-012016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278925282NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2026-05-11
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
00814848020836Contour Hand Wrist 0.55TQUALITY ELECTRODYNAMICS LLCMOS2026-04-23
00850083516000Nuzzle Body Array, 1.5TInkspace Imaging, Inc.MOS2026-04-21
00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)Inkspace Imaging, Inc.MOS2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)Inkspace Imaging, Inc.MOS2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)Inkspace Imaging, Inc.MOS2026-04-21
00884838130548DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130555DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130562DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130579DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130586DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130593DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130609DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130616DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130623DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132597DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132603DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838093089MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838093096MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838093102MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098190MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098367MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098510MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838108073MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838118997MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-10-01
00884838119000MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-10-01
00884838108080MRI CoilsPhilips Ds North America LLCMOS2025-09-30
00884838111172DUNLEEPhilips Medical Systems Nederland B.V.MOS2025-09-30