FDA.reportPublic FDA data

SmartFrame

Primary DI
00850359007034
Brand
SmartFrame
Company
Clearpoint Neuro, Inc.
Model
CP-NGS-11-HC-SCM
Catalog number
CP-NGS-11-HC-SCM
Device description
SMARTFrame Scalp Mount Kit w/ HC
Published
2021-01-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
00850359007034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850359007034008503590070348503590070340850359007034

GMDN Terms#

Term, Definition table
TermDefinition
Manual cranial rotary handpiece, single-useA manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). 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
119078557
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013266012Hummingbird® Patient MonitorHICP200HICP2002019-10-14
00850013266029Hummingbird® SynergyDuoH610H6102019-10-10
00850013266036Hummingbird® Parenchymal CatheterH110H1102019-10-10
00850013266180Hummingbird® Cranial Access Kit IC42-DIC42-D2020-01-29
00850013266197Hummingbird® Cranial Access KitIC42IC422020-01-29
00850013266203IRRAflow Tube SetICDS 030ICDS 0302023-11-02
00850013266234HummingbirdCK 402023-10-13
00850013266241HummingbirdCK 422023-10-13
00850013266272IRRAflow Cranial Access BoltICB 0102025-07-24
00868643000401IRRAflow®ICCU 020ICCU 0202019-01-22
00868643000463IRRAflow Laser Leveler PackageICLS 010ICLS 0102024-06-10
00868643000470IRRAflow Drainage Collection SystemDCS 010DCS 0102019-09-30
00868643000487Hummingbird® Cranial Access KitIC40DIC40-D2019-10-10
00868643000494Hummingbird® Cranial Access KitIC40IC402019-10-10
00850013266258IRRAflow Catheter 2.0+ICAT 0302025-05-07
00850013266005Hummingbird Cranial Access KitIC40IC402023-12-08
00850013266227Hummingbird Cranial Access KitIC422023-12-08
00850013266104Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor700033270003322020-05-28
00868643000418IRRAflow® Cassette and Tube SetICDS 020ICDS 0202019-01-22
00868643000425IRRAflow® 1.5 CatheterICGS 010ICGS 0102019-01-22

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