FDA.reportPublic FDA data

Estacore-Pro Automatic Biopsy Needle

Primary DI
08681672052676
Brand
Estacore-Pro Automatic Biopsy Needle
Company
GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETI
Model
GEP2020-S
Catalog number
GEP2020-S
Device description
This a guillotine type automatic biopsy needle with a stylet with sample notch and a cm marked echogenic cutting cannula.
Published
2023-09-01
Public version status
New
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
KNWInstrument, Biopsy

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08681672052676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08681672052676086816720526768681672052676

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
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08699158346362Vescut Automatic Biopsy NeedleGVS1416GVS14162026-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
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