FDA.reportPublic FDA data

n.a.

Primary DI
04048551160992
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
40800090
Device description
Transport Case Naviagtion
Published
2016-09-23
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122096000KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEMKARL STORZ Endoscopy-America, Inc.2012-09-27HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551160992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551160992040485511609924048551160992

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical navigation device tracking systemAn assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315731430
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662724000611neuromate - Tool guideRENISHAW MAYFIELDHAW2026-07-14
03662724000642neuromate - Tool guideRENISHAW MAYFIELDHAW2026-07-14
03662724000727neuromate - frame attachmentRENISHAW MAYFIELDHAW2026-07-14
00650551006787PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2026-07-07
G076A900588A0Localite TMS Navigator TSLOCALITE GmbHHAW2026-06-22
07340201502976Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-06-10
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