FDA.reportPublic FDA data

CRW®

Primary DI
M248MRCTF21
Brand
CRW®
Company
INTEGRA LIFESCIENCES CORPORATION
Model
MRCTF2
Device description
Multi-Modality Patient Markers, MR/CT
Published
2016-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological stereotaxic Instrument
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010548000
K100096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010548000MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)Radionics, A Division of Tyco Healthcare Group LP2001-03-12HAW
K100096000LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHARTIntegra Radionics, Inc.2010-04-22IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780210856PrimaryGS10
M248MRCTF21SecondaryHIBCC0
00381780210859Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178021085610381780210856
00381780210859003817802108593817802108590381780210859

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
963856096
Device count
100
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
10381780272618Omni-Tract®11908119082018-02-23
20705031004334BioPatch™31502016-06-20
20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
006283415208297D Surgical FLASH EVD Procedural Kit7D Surgical ULCHAW2026-04-08
006283415208367D Surgical FLASH EVD Non-Sterile Kit7D Surgical ULCHAW2026-04-08
006283415208437D Surgical FLASH EVD Sterile Kit7D Surgical ULCHAW2026-04-08
00628341521352FLASH EVD System7D Surgical ULCHAW2026-04-08
00840277411815Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
04056481146429Automatic RegsitrationBrainlab SEHAW2026-02-20
04056481146702Curve NavigationBrainlab SEHAW2025-10-13
04056481145828Microscope NavigationBrainlab SEHAW2025-06-11
04056481145620Alignment Reduction Tube Cranial 8.0 mm / 10.0 mmBrainlab SEHAW2025-02-24
04056481145637Alignment Guide Tube Cranial 4.9 mm / 8.0 mmBrainlab SEHAW2025-02-24
04056481145903Alignment Bone Anchor Cranial 2.1 mm / 4.9 mmBrainlab SEHAW2025-02-24
04056481146047Cirq Robotic Tracking Array 10.0Brainlab SEHAW2025-02-24
04056481146337Alignment Software Cranial with LITTBrainlab SEHAW2025-02-24
04056481145514Z-touch Laser Registration PointerBrainlab SEHAW2025-02-13
00850002461343BiomarC®Carbon Medical Technologies, Inc.IYE2024-07-23
00850002461350Carbon Bright ®Carbon Medical Technologies, Inc.IYE2024-07-23
04056481144630Ultrasound NavigationBrainlab SEHAW2024-04-26
00850016008176VeraFormViscus Biologics LLCIYE2024-01-16
04056481144845Automatic Registration iMRIBrainlab SEHAW2023-11-20
04056481145392DRAPELINK REF ADAPTER AUTO-REG IMRIBrainlab SEHAW2023-10-16
04056481145101Automatic RegistrationBrainlab SEHAW2023-09-22
04056481143817Alignment Bone Anchor Cranial 2.1/3.8Brainlab SEHAW2023-09-18
04056481144395Alignment Guide Tube Cranial 2.5/7.5Brainlab SEHAW2023-09-18
04056481144401Alignment Guide Tube Cranial 4.0/7.5Brainlab SEHAW2023-09-18
04056481144418Alignment Guide Tube Cranial 3.8/7.5Brainlab SEHAW2023-09-18
04056481144432Alignment Reduction Tube Cranial 2.5/4.0Brainlab SEHAW2023-09-18
04056481144487Alignment Software CranialBrainlab SEHAW2023-09-18
04056481143848Cranial NavigationBrainlab SEHAW2023-08-02
04056481144500Curve Navigation 17700Brainlab SEHAW2023-05-22
04056481144685Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mmBrainlab SEHAW2023-05-05