FDA.reportPublic FDA data

TGS Navigation

Primary DI
07613327413083
Brand
TGS Navigation
Company
Stryker Leibinger GmbH & Co. KG
Model
8000-010-003
Catalog number
8000-010-003
Device description
Electromagnetic Navigation Unit
Published
2018-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGWEar, Nose, and Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327413083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327413083076133274130837613327413083

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 typically 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/localizers, 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].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep Away from Sunlight
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Other Special Storage and Handling Conditions
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@stryker.com

Regulatory Flags#

DUNS number
316153956
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04546540143273NA01-1973001-197302016-12-08
04546540166623NA09-0146109-014612017-01-11
04546540166630NA09-0146209-014622017-01-11
04546540215161NA37-1027237-102722016-12-08
04546540215222NA37-1041137-104112016-12-08
04546540215291NA37-1093037-109302016-12-08
04546540215413NA37-1246137-124612016-12-08
04546540217059NA41-3679241-367922016-12-08
04546540217066NA41-3679341-367932016-12-08
04546540217073NA41-3679441-367942016-12-08
04546540217080NA41-3679541-367952016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006427Stealth AXiSMEDTRONIC NAVIGATION, INC.PGW2026-04-24
00763000738358AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738365AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738372AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738389AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738396AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
04056481146702Curve NavigationBrainlab SEPGW2025-10-13
04260759930003Integrated HeadrestFiagon GmbHPGW2025-06-25
04260759930133Navigation Unit Cube4DFiagon GmbHPGW2025-01-16
042607599301574K Navigation Unit Cube4DFiagon GmbHPGW2025-01-16
04260759930249Navigation SensorFiagon GmbHPGW2025-01-16
04260759930300FlexPointerFiagon GmbHPGW2025-01-16
04260759930317FlexPointer 1.5 mmFiagon GmbHPGW2025-01-16
04260759930324FlexTube 3mmFiagon GmbHPGW2025-01-16
04260759930331FlexTube 4mmFiagon GmbHPGW2025-01-16
04260759930348PointerTube KeatFiagon GmbHPGW2025-01-16
04260759930355PointerTube KennedyFiagon GmbHPGW2025-01-16
04260759930447Localizer Adhesive Pad C-TypeFiagon GmbHPGW2025-01-16
04260759930515Adhesive PadFiagon GmbHPGW2024-09-02
04260759930119RegistrationPointerFiagon GmbHPGW2024-09-02
04260759930126VirtuEyeFiagon GmbHPGW2024-09-02
04260759930256Navigation Headrest UniversalFiagon GmbHPGW2024-09-02
04260759930362PointerShell 4 mm Fiagon GmbHPGW2024-09-02
04260759930379PointerShell 5 mm Fiagon GmbHPGW2024-09-02
04260759930386PointerShell 3 mm Fiagon GmbHPGW2024-09-02
04260759930393PointerShell UniversalFiagon GmbHPGW2024-09-02
14260759930512Adhesive PadFiagon GmbHPGW2024-09-02
00763000768744StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27
00763000769017StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27
00763000769123StealthStation S8MEDTRONIC NAVIGATION, INC.PGW2023-11-27