FDA.reportPublic FDA data

Curaway

Primary DI
06936666568636
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
BNMAB-1-1.2(18G)/25
Device description
Bone Marrow Biopsy Needle
Published
2026-07-31
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

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
K242322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242322000Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd.2025-01-24KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936666568633PackageGS130In Commercial Distribution
26936666568630PackageGS12In Commercial Distribution
06936666568636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693666656863316936666568633
2693666656863026936666568630
06936666568636069366665686366936666568636

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy procedure kitA packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.

Regulatory Flags#

DUNS number
412923111
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936666568643CurawayBNMAB-1-1.2(18G)/402026-07-31
06936666568650CurawayBNMAB-1-1.2(18G)/552026-07-31
06936666568667CurawayBNMAB-1-1.6(16G)/252026-07-31
06936666568674CurawayBNMAB-1-1.6(16G)/402026-07-31
06936666568681CurawayBNMAB-1-1.6(16G)/552026-07-31
06936666568698CurawayBNMAB-1-1.8(15G)/252026-07-31
06936666568704CurawayBNMAB-1-1.8(15G)/402026-07-31
06936666568711CurawayBNMAB-1-1.8(15G)/552026-07-31
06936666568728CurawayBNMAB-1-2.1(14G)/252026-07-31
06936666568735CurawayBNMAB-1-2.1(14G)/402026-07-31
06936666568742CurawayBNMAB-1-2.1(14G)/552026-07-31
06936666568759CurawayBNMA/CB-1-2.4(13G)/702026-07-31
06936666568766CurawayBNMA/CB-1-2.4(13G)/1002026-07-31
06936666568773CurawayBNMA/CB-1-2.4(13G)/1502026-07-31
06936666568780CurawayBNMA/CB-1-3.0(11G)/702026-07-31
06936666568797CurawayBNMA/CB-1-3.0(11G)/1002026-07-31
06936666568803CurawayBNMA/CB-1-3.0(11G)/1502026-07-31
06936666568810CurawayBNMA/CB-1-3.5(9G)/702026-07-31
06936666568827CurawayBNMA/CB-1-3.5(9G)/1002026-07-31
06937278628268CurawayBN-MAR-1/23082026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936666568643CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568650CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568667CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568674CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568681CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568698CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568704CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568711CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568728CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568735CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568742CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568759CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568766CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568773CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568780CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568797CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568803CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568810CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06936666568827CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628268CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628299CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628305CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628312CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628329CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628336CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628343CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628350CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628367CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628374CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31
06937278628381CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-07-31