FDA.reportPublic FDA data

GTK Disposable Needle Guides

Primary DI
08699158340056
Brand
GTK Disposable Needle Guides
Company
GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETI
Model
GTK05
Catalog number
GTK05
Device description
Sterile disposable needle guide for Shimadzu transducers
Published
2022-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
08699158340056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08699158340056086991583400568699158340056

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08681672050375Maxicore-M Automatic Biopsy Gun NeedleGPN1410-MGPN1410-M2023-09-01
08681672050382Maxicore-M Automatic Biopsy Gun NeedleGPN1415-MGPN1415-M2023-09-01
08681672050399Maxicore-M Automatic Biopsy Gun NeedleGPN1420-MGPN1420-M2023-09-01
08681672050412Maxicore-M Automatic Biopsy Gun NeedleGPN1610-MGPN1610-M2023-09-01
08681672050429Maxicore-M Automatic Biopsy Gun NeedleGPN1615-MGPN1615-M2023-09-01
08681672050436Maxicore-M Automatic Biopsy Gun NeedleGPN1620-MGPN1620-M2023-09-01
08681672050443Maxicore-M Automatic Biopsy Gun NeedleGPN1625-MGPN1625-M2023-09-01
08681672050450Maxicore-M Automatic Biopsy Gun NeedleGPN1809-MGPN1809-M2023-09-01
08681672050467Maxicore-M Automatic Biopsy Gun NeedleGPN1810-MGPN1810-M2023-09-01
08681672050474Maxicore-M Automatic Biopsy Gun NeedleGPN1815-MGPN1815-M2023-09-01
08681672050481Maxicore-M Automatic Biopsy Gun NeedleGPN1820-MGPN1820-M2023-09-01
08681672050498Maxicore-M Automatic Biopsy Gun NeedleGPN1825-MGPN1825-M2023-09-01
08681672050504Maxicore-M Automatic Biopsy Gun NeedleGPN1830-MGPN1830-M2023-09-01
08681672050511Maxicore-M Automatic Biopsy Gun NeedleGPN2010-MGPN2010-M2023-09-01
08681672050528Maxicore-M Automatic Biopsy Gun NeedleGPN2015-MGPN2015-M2023-09-01
08681672050535Maxicore-M Automatic Biopsy Gun NeedleGPN2020-MGPN2020-M2023-09-01
08681672050771Semi automatic Biopsy NeedleGSN1416GSN14162023-09-01
08681672050788Semi automatic Biopsy NeedleGSN1616GSN16162023-09-01
08681672050795Semi automatic Biopsy NeedleGSN1816GSN18162023-09-01
08681672052003Estacore-Pro Automatic Biopsy NeedleGEP1409GEP14092023-09-01

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Primary DI, Brand, Company table
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