FDA.reportPublic FDA data

BIOSUC-C7

Primary DI
04526737120010
Brand
BIOSUC-C7
Company
HAKKO CO.,LTD.
Model
BIO20100
Device description
20G x 100mmwith suction syringe
Published
2016-09-23
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013108000BIOSUCHakko Medical Co., Ltd.2002-04-04KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14526737120017PackageGS110In Commercial Distribution
04526737120010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1452673712001714526737120017
04526737120010045267371200104526737120010

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Needle Gauge20Gauge

Contacts#

Phone, Email table
PhoneEmail
513-271-2117SAst@havels.com

Regulatory Flags#

DUNS number
693273427
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04526737171135EchoStim EBEB-21502022-10-01
04526737171159EchoStim EBEB-211002022-10-01
04526737171173EchoStim MSKEBA-21502022-10-01
04526737171197EchoStim MSKEBA-211002022-10-01
04526737171203EchoStim MSKEBA-211502022-10-01
04526737171210EchoStim MSKEBA-22502022-10-01
04526737171227EchoStim MSKEBA-22802022-10-01
04526737171234EchoStim MSKEBA-221002022-10-01
14526737171132EchoStim EBEB-21502022-10-01
04526737171142EchoStim EBEB-21802022-10-01
14526737171156EchoStim EBEB-211002022-10-01
04526737171166EchoStim EBEB-211502022-10-01
14526737171170EchoStim MSKEBA-21502022-10-01
04526737171180EchoStim MSKEBA-21802022-10-01
14526737171194EchoStim MSKEBA-211002022-10-01
14526737171200EchoStim MSKEBA-211502022-10-01
14526737171217EchoStim MSKEBA-22502022-10-01
14526737171224EchoStim MSKEBA-22802022-10-01
14526737171231EchoStim MSKEBA-221002022-10-01
04526737120041Sonopsy-C1SON21502016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131882983BMAN BCOR Bone Marrow Aspirate KitSurgentec, LLCKNW2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)Surgentec, LLCKNW2026-08-19
00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
06937278634917CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634924CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634931CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634962CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634979CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634986CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635013CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635020CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635037CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635068CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635075CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635082CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635112CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635129CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635136CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635167CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635174CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635181CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635211CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635228CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635235CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635266CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635273CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635280CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635310CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635327CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15