FDA.reportPublic FDA data

ClearPoint

Primary DI
00850376007013
Brand
ClearPoint
Company
MRI INTERVENTIONS, INC.
Model
CP- HFF-412-01
Catalog number
CP- HFF-412-01
Device description
ClearPoint Philips Achieva Table Head Fixation Frame
Published
2016-08-12
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
HBLHolder, Head, Neurosurgical (Skull Clamp)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091439000HEAD FIXATION ARC AND TABLE BASESurgivision, Inc.2009-08-25HBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850376007013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850376007013008503760070138503760070130850376007013

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic radiosurgical invasive head frameA device intended to be affixed to a patient's skull to enable precise localization of an area within the brain targeted for radiosurgical procedures (e.g., radiation treatment of a brain tumour). It is typically an assembly that includes a head ring or a head frame that is attached to the patient's head with fixation screws partially-embedded into the skull, an arc mechanism for setting target coordinates, and localizer frames and adaptors for precision placement to the simulator and imaging system [e.g., computed tomography (CT), magnetic resonance imaging (MRI), linear accelerator]. This is a reusable 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
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
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
10381780253716MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256113MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
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10381780256144MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256151MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256175MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256182MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256199MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256205MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256212MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256229MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256236MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256243MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256250MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256267MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256274MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256281MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256687MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780025757MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025764MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025771MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025788MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025795MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025818MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253334MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253341MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253358MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253365MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253372MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26