FDA.reportPublic FDA data

GTK Disposable Needle Guides

Primary DI
08681672052966
Brand
GTK Disposable Needle Guides
Company
GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETI
Model
GTK141
Catalog number
GTK141
Device description
Sterile disposable needle guide for GE transducer
Published
2022-03-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08681672052966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08681672052966086816720529668681672052966

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep awway from Sun light
Special Storage Condition, Specify00Storage environment temperature between 5-30 degrees celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
(908)699-0662info@geotekmedicalusa.com

Regulatory Flags#

DUNS number
503024386
Device count
1
Kit
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
08681672056520MaxiCore-M Reusable Automatic Biopsy GunGBG-MGBG-M2026-09-22
08681672055950Vescut Automatic Biopsy NeedleGVS2016GVS20162026-05-04
08681672055974Vescut Automatic Biopsy Needle w/coaxialGVS2009-XGVS2009-X2026-05-04
08681672055981Vescut Automatic Biopsy Needle w/coaxialGVS2016-XGVS2016-X2026-05-04
08683255230259Vescut Automatic Biopsy NeedleGVS1412GVS14122026-05-04
08683255230266Vescut Automatic Biopsy NeedleGVS1612GVS16122026-05-04
08683255230273Vescut Automatic Biopsy NeedleGVS1812GVS18122026-05-04
08683255230280Vescut Automatic Biopsy NeedleGVS2009GVS20092026-05-04
08683255230297Vescut Automatic Biopsy Needle w/coaxialGVS1412-XGVS1412-X2026-05-04
08683255230303Vescut Automatic Biopsy Needle w/coaxialGVS1612-XGVS1612-X2026-05-04
08683255230310Vescut Automatic Biopsy Needle w/coaxialGVS1625-XGVS1625-X2026-05-04
08683255230327Vescut Automatic Biopsy Needle w/coaxialGVS1812-XGVS1812-X2026-05-04
08683255230334Vescut Automatic Biopsy Needle w/coaxialGVS1825-XGVS1825-X2026-05-04
08683255230341Vescut Automatic Biopsy Needle w/coaxialGVS2020-XGVS2020-X2026-05-04
08699158346300Vescut Automatic Biopsy NeedleGVS1409GVS14092026-05-04
08699158346317Vescut Automatic Biopsy Needle w/coaxialGVS1409-XGVS1409-X2026-05-04
08699158346324Vescut Automatic Biopsy NeedleGVS1410GVS14102026-05-04
08699158346331Vescut Automatic Biopsy Needle w/coaxialGVS1410-XGVS1410-X2026-05-04
08699158346348Vescut Automatic Biopsy NeedleGVS1415GVS14152026-05-04
08699158346355Vescut Automatic Biopsy Needle w/coaxialGVS1415-XGVS1415-X2026-05-04

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Primary DI, Brand, Company table
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00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
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00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
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