FDA.report

GTK Disposable Needle Guides

Primary DI
08683255232147
Brand
GTK Disposable Needle Guides
Company
GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETI
Model
GTK150
Catalog number
GTK150
Device description
Sterile disposable needle guide for BK transducer
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

Related Records

Product Codes

CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08683255232147PrimaryGS10

GMDN Terms

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

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

Sterilization Methods

Method
Ethylene Oxide

Contacts

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

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