FDA.reportPublic FDA data

Compass International

Primary DI
B169RU1500
Brand
Compass International
Company
Compass International
Model
RU-150
Catalog number
RU-150
Device description
150 MM Ruler
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B169RU1500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical ruler, single-useA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be bendable to fit on the measured surfaces. It is not dedicated to wound measurements. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
809466410
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B169CYGERG10D0Compass InternationalCYG-ERG-10DCYG-ERG-10D2016-08-12
00860009258129COMPASS CT Adaptation Stereotactic SystemPION-20CT-NBAR-102026-03-18
00860009258136COMPASS Stereotactic Retractor SystemPION-20RE-202026-03-18
00860009258105COMPASS CYGNUS-PFS IGS SystemCYG-PFSN-10TPCYG-PFSN-10TP2026-01-29
00860009258112COMPASS Stereotactic SystemPION-20PION-202026-01-29
B169RU3000Compass InternationalRU-300RU-3002016-08-26
B169CYG10B2TP0Compass InternationalCYG-10-B2TPCYG-10-B2TP2016-09-13
B169CYG10BTP0Compass InternationalCYG-10-BTPCYG-10-BTP2016-09-13
B169CYG10LPTP0Compass InternationalCYG-10-LPTPCYG-10-LPTP2016-09-13
B169CYG10LSTP0Compass InternationalCYG-10-LSTPCYG-10-LSTP2016-09-13
B169CYG10PTP0Compass InternationalCYG-10-PTPCYG-10-PTP2016-09-13
B169CYG10STP0Compass InternationalCYG-10-STPCYG-10-STP2016-09-13
B169CYG14FSCT100Compass InternationalCYG-14F-SCT10CYG-14F-SCT102016-09-13
B169CYG4FCT100Compass InternationalCYG-4F-CT10CYG-4F-CT102016-08-12
B169CYG4FCT10TP0Compass InternationalCYG-4F-CT10TPCYG-4F-CT10TP2016-09-13
B169CYG5FNPT100Compass InternationalCYG-5F-NPT10CYG-5F-NPT102016-09-13
B169CYG5FNPT10TP0Compass InternationalCYG-5F-NPT10TPCYG-5F-NPT10TP2016-09-13
B169CYG9FSCT100Compass InternationalCYG-9F-SCT10CYG-9F-SCT102016-09-13
B169CYG9FSCT10TP0Compass InternationalCYG-9F-SCT10TPCYG-9F-SCT10TP2016-09-13
B169REG30BC0Compass InternationalREG-30-BCREG-30-BC2016-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
04056481146702Curve NavigationBrainlab SEHAW2025-10-13
00889024679559ALLEN WRENCH 8MMMEDTECHHAW2025-07-15
00887868539978SEEG DRILL ADAPTOR 2.70MMMEDTECHHAW2025-06-24
00889024663282PLANNING STATION - ROSA ONE - USAMEDTECHHAW2024-02-20
00887868585951ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2023-10-30
03760244031129Trnsnsl Endscp Ovoid Ø6.18mm HolderMEDTECHHAW2023-10-27
04056481144500Curve Navigation 17700Brainlab SEHAW2023-05-22
03760244034793ROSA ONE SURGICAL ASSISTANT (US)MEDTECHHAW2022-06-20
03760244034922PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244035127PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244034625SEEG DRILL ADAPTOR Ø2.5MMMEDTECHHAW2022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MMMEDTECHHAW2022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MMMEDTECHHAW2022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MMMEDTECHHAW2022-02-18
03760244034663SEEG DRILL ADAPTOR Ø3.2MMMEDTECHHAW2022-02-18
03760244032195Optical distance sensorMEDTECHHAW2021-06-15
03760244034304ROBOT ROSA ONE (USA)MEDTECHHAW2021-05-31
03760244034403PLANNING STATION Rosa One -USAMEDTECHHAW2021-05-31
04056481143503Kick 2 Navigation StationBrainlab SEHAW2021-05-31
03760244030962CRW frame adaptorMEDTECHHAW2020-11-20
03760244031914LEKSELL FRAME REGISTRATION PLATESMEDTECHHAW2020-10-20