FDA.reportPublic FDA data

M Biopsy Automatic Disposable Biopsy Needle

Primary DI
06954414667592
Brand
M Biopsy Automatic Disposable Biopsy Needle
Company
Canyon Medical Inc.
Model
NS6011625
Device description
Automatic Disposable Biopsy Needle
Published
2024-01-31
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

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233031000M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy NeedleCanyon Medical, Inc.2024-01-17KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06954414667592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954414667592069544146675926954414667592

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, non-medicatedA collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527310648
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
06954414670110Polyvinyl Alcohol Embolic MicrospheresPB-1012026-02-26
06954414670127Polyvinyl Alcohol Embolic MicrospheresPB-1022026-02-26
06954414670134Polyvinyl Alcohol Embolic MicrospheresPB-1032026-02-26
06954414670141Polyvinyl Alcohol Embolic MicrospheresPB-2012026-02-26
06954414670158Polyvinyl Alcohol Embolic MicrospheresPB-2022026-02-26
06954414670165Polyvinyl Alcohol Embolic MicrospheresPB-2032026-02-26
06954414670172Polyvinyl Alcohol Embolic MicrospheresPB-4012026-02-26
06954414670189Polyvinyl Alcohol Embolic MicrospheresPB-4022026-02-26
06954414670196Polyvinyl Alcohol Embolic MicrospheresPB-4032026-02-26
06954414670202Polyvinyl Alcohol Embolic MicrospheresPB-6012026-02-26
06954414670219Polyvinyl Alcohol Embolic MicrospheresPB-6022026-02-26
06954414670226Polyvinyl Alcohol Embolic MicrospheresPB-6032026-02-26
06954414670233Polyvinyl Alcohol Embolic MicrospheresPB-8012026-02-26
06954414670240Polyvinyl Alcohol Embolic MicrospheresPB-8022026-02-26
06954414670257Polyvinyl Alcohol Embolic MicrospheresPB-8032026-02-26
06954414670264Polyvinyl Alcohol Embolic MicrospheresPB-10512026-02-26
06954414670271Polyvinyl Alcohol Embolic MicrospheresPB-10522026-02-26
06954414670288Polyvinyl Alcohol Embolic MicrospheresPB-10532026-02-26
06954414670295Polyvinyl Alcohol Embolic MicrospheresPW-1012026-02-26
06954414670301Polyvinyl Alcohol Embolic MicrospheresPW-1022026-02-26

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
06937278635983CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636003CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636010CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636027CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636034CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636041CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636058CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636065CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636072CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636089CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636096CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636102CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636119CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636126CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636133CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636140CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636157CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636164CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636171CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636188CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636195CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636201CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636218CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636225CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636232CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636249CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636256CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31