FDA.report

Semi automatic Biopsy Needle w/coaxial

Primary DI
08681672055622
Brand
Semi automatic Biopsy Needle w/coaxial
Company
GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETI
Model
GSN1816-X
Catalog number
GSN1816-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

Related Records

Contact Domains

Product Codes

CodeName
KNWInstrument, Biopsy

Product Code Classifications

CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08681672055622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08681672055622086816720556228681672055622

GMDN Terms

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

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

Sterilization Methods

Method

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
false

Other Devices From This Company

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06974405095210CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-26
06974405095227CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-26
06974405095067CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-25
00841911100508Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102281Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102458Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102489Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102496Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102632Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00801741234187EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-09
10801741234153EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
10801741234160EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
00801741236167EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
00801741234194EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741234248EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741234262EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741235221EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
10801741234092EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
10801741234139EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
00801741234200EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
10801741234115EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10801741234146EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10801741234177EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10850075308016HYDRACELL-ORTHO-5RANFAC CORP.KNW2025-09-25
10850075308030HYDRACELL-ORTHO-10RANFAC CORP.KNW2025-09-25
10850075308047HYDRACELL-EXT-5RANFAC CORP.KNW2025-09-25
10850075308061HYDRACELL-EXT-10RANFAC CORP.KNW2025-09-25
08058983746639TRAP EASYH.S. HOSPITAL SERVICE SPAKNW2025-09-23
10810563022725OmniBone Bone Biopsy Kit with 11 Gauge 68mm lengthVARIAN MEDICAL SYSTEMS, INC.KNW2025-09-18
10810563022732OmniBone Bone Biopsy Kit with 11 Gauge 108mm lengthVARIAN MEDICAL SYSTEMS, INC.KNW2025-09-18