FDA.reportPublic FDA data

Medichoice

Primary DI
10885632107795
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
BMA652
Device description
X Rx Tray Aspiration Bone Marrow Biopsy With Needle Single-Patient Use Latex-Free Sterile MediChoice
Published
2016-08-20
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

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
K061570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061570000I-STYLE BONE MARROW ASPIRATION NEEDLEBusse Hospital Disposables, Inc.2006-07-03KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885632107793PackageGS110In Commercial Distribution
10885632107795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563210779350885632107793
1088563210779510885632107795

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow collection/transfusion setA sterile collection of instruments, pharmaceuticals, and other items intended for use in combination to collect and/or deliver bone marrow. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00
Special Storage Condition, Specify00Avoid Freezing and Excessive Heat

Regulatory Flags#

DUNS number
007941230
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632522543SurgiTrackSM450030A7E12026-06-04
10885632522512SurgiTrackSM45004591012026-06-03
10885632522222SurgiTrackSM45005945A12026-06-01
10885632522109SurgiTrackSM4501306C092026-05-29
10885632522079SurgiTrackSM450045D71A2026-05-28
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632521607SurgiTrackSM4500452F842026-05-19
10885632521638SurgiTrackSM45007841332026-05-19
10885632521522SurgiTrackSM4500410A672026-05-18

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