FDA.reportPublic FDA data

TGS

Primary DI
00850002250220
Brand
TGS
Company
STRYKER CORPORATION
Model
TGSGW
Catalog number
8000-060-009
Device description
Guidewire
Published
2020-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
10850002250227PackageGS11In Commercial Distribution
00850002250220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000225022710850002250227
00850002250220008500022502208500022502200850002250220

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, single-useA slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

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