FDA.reportPublic FDA data

ClearPoint

Primary DI
00850376007039
Brand
ClearPoint
Company
MRI INTERVENTIONS, INC.
Model
CP-FFSMPL-02
Catalog number
CP-FFSMPL-02
Device description
ClearPoint Multi-Positional Lower HFF Screws for Philips
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
00850376007039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850376007039008503760070398503760070390850376007039

GMDN Terms#

Term, Definition table
TermDefinition
Stationary liquid oxygen containerA device designed as a large reservoir for the storage of liquid oxygen (LOX) prior to its distribution and use. It typically consists of a large capacity (e.g., 10 or 100 litres) double vessel bulk tank (i.e., an inner vessel to contain the liquid oxygen and an outer vessel for protection); vacuum in the space between both vessels provides thermal insulation for the LOX. The container typically includes evaporation coils that slowly boil the LOX into gas and is used in supply centres and in most large healthcare facilities before the distribution of LOX either as liquid or gas; some smaller containers are used at home to fill portable liquid oxygen units.

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
949-900-6833nfo@mriinterventions.com

Regulatory Flags#

DUNS number
959181160
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
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
10381780256120MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256137MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
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