FDA.reportPublic FDA data

Cranial Guidance Software

Primary DI
07613327538410
Brand
Cranial Guidance Software
Company
Stryker Leibinger GmbH & Co. KG
Model
6000-670-300
Catalog number
6000-670-300
Device description
Cranial Guidance Enable
Published
2023-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07613327538410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327538410076133275384107613327538410

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic/optical surgical navigation device tracking systemA mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/localizers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
37613327122962NA29-9300329-930032018-04-13
04546540274250NA64-0013264-001322017-01-11
07613327122893NA29-9300129-930012017-12-01
07613327122909NA29-9200129-920012017-03-31
07613327122916NA29-9200329-920032017-03-31
07613327122930NA29-9200229-920022017-03-31
07613327122947NA29-9100229-910022017-03-31
07613327122978NA29-9300229-930022017-12-01
07613327123326NA29-9200429-920042017-03-31
37613154881872PINABALL6003-003-0906003-003-0902016-09-21
57613252088436TLS, Quintube663066302016-08-24
07613327465532NA92-0023292-002322019-05-03
07613327465549NA92-0023092-002302019-05-03
04546540134790NA01-0323001-032302017-01-11
04546540134974NA01-0401001-040102016-12-08
04546540134998NA01-0407001-040702016-12-08
04546540135018NA01-0410001-041002016-12-08
04546540138477NA01-0956101-095612016-12-08
04546540141514NA01-1531501-153152017-01-11
04546540143242NA01-1971501-197152016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00650551006701PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2026-06-09
00650551006718PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2026-06-09
00650551006725PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2026-06-09
00650551006732PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2026-06-09
00763000811129MedtronicMEDTRONIC NAVIGATION, INC.HAW2026-06-07
00860012056828Zeta Navigation SystemZeta Surgical Inc.HAW2026-06-02
08720892330826Ball Joint Guide Array (BJGA)-Navigation SetBayer Medical Care B.V.HAW2026-04-24
08720892330833Ball Joint Guide Array (BJGA)-Guide SetBayer Medical Care B.V.HAW2026-04-24
07340201501887Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2025-03-31
10381780542278CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542285CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542292Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-03
G076A012354A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
G076A012355A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
07613327499711N/AStryker Leibinger GmbH & Co. KGHAW2023-03-23
07613327500516N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500561N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500578N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327503265N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
10603295522850VELYSDEPUY (IRELAND)HAW2021-07-30
07613327413076n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413090n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413205n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
10603295493624SIGMADEPUY ORTHOPAEDICS, INC.HAW2018-04-19
10650551098277PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2018-01-28
10381780167334CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252252CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252351Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252368Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252375CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14