SUREcore Plus Biopsy Instrument

Primary DI
00860014338625
Brand
SUREcore Plus Biopsy Instrument
Company
URO-1, INC.
Model
SP-LA18-22
Catalog number
SP-LA18-22
Device description
"A needle biopsy system consisting of a needle and an instrument (""gun"") to facilitate biopsy of soft tissue. The needle is advanced to the target tissue under image guidance and then the instrument fires the needle in order to obtain a core of tissue that then is prepared for analysis by a pathologist."
Published
2026-05-08
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
00860014338618PackageGS11In Commercial Distribution
00860014338625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014338618008600143386188600143386180860014338618
00860014338625008600143386258600143386250860014338625

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy gun handpiece, mechanicalA hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. 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 reusable device.

Contacts#

Phone, Email table
PhoneEmail
3369305464info@uro1medical.com

Regulatory Flags#

DUNS number
082407801
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014338663SUREcore Plus Biopsy InstrumentSP-LA18-25SP-LA18-252026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103776Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-06-09
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
06937278635983CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
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06937278636010CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
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