FDA.reportPublic FDA data

Semi automatic Biopsy Needle w/coaxial

Primary DI
08699158344207
Brand
Semi automatic Biopsy Needle w/coaxial
Company
GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETI
Model
GSN2010-X
Catalog number
GSN2010-X
Device description
It is a disposable spring loaded biopsy device with a stylet with sample notch and a cm marked echogenic cutting cannula. GEOTEK semiautomatic biopsy needle has two advancement options: 10mm and 20mm
Published
2023-09-01
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
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08699158344207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08699158344207086991583442078699158344207

GMDN Terms#

Term, Definition table
TermDefinition
Side-notch biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. 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

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
false

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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00841911100508Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
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00841911102458Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102489Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102496Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
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