FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
00849233013261
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
653
Catalog number
653
Device description
Bone Marrow Biopsy/Aspiration Tray w/ Biopsy Needle
Published
2016-09-02
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
PRVGastro-Urology Biopsy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRVGastro-Urology Biopsy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233013268PackageGS110In Commercial Distribution
00849233013261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301326810849233013268
00849233013261008492330132618492330132610849233013261

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1 (631) 435-4711mail@busseinc.com

Regulatory Flags#

DUNS number
002418234
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849233010277Busse Hospital Disposables949794972020-04-02
00849233010376Busse Hospital Disposables954595452020-04-03
00849233004481Busse Hospital Disposables249124912016-09-20
00849233017276Busse Hospital Disposables40432026-05-28
00849233015906Busse Hospital DisposablesB84822026-05-27
00849233016538Busse Hospital Disposables40122026-05-21
00849233016958Busse Hospital Disposables40172026-05-21
00849233003750Busse Hospital DisposablesB1326B13262020-06-25
00849233003767Busse Hospital DisposablesB1328B13282020-06-25
00849233005129Busse Hospital DisposablesB1435B14352020-10-20
00849233014350Busse Hospital Disposables29112026-04-27
00849233014817Busse Hospital Disposables29602026-04-27
00849233000193Busse Hospital Disposables6007R16007R12016-09-14
00849233006256Busse Hospital Disposables173917392021-08-18
00849233011304Busse Hospital Disposables289328932016-09-13
00849233011359Busse Hospital Disposables327232722016-09-13
00849233011724Busse Hospital Disposables562156212016-09-13
00849233015036Busse Hospital Disposables356935692016-09-13
00849233015869Busse Hospital Disposables679067902016-09-13
00849233017733Busse Hospital Disposables679167912016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233014817Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2026-04-27
00849233013575Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2025-06-23
10849233013572Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2025-06-23
00849233002012Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2020-11-23
00849233013827Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2020-11-23
10849233002019Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2020-11-23
10849233013824Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2020-11-23
00849233015401Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2020-04-08
00724995182885HistolockUS EndoscopyPRV2020-04-02
00724995182892HistolockUS EndoscopyPRV2020-04-02
10724995182882HistolockUS EndoscopyPRV2020-04-02
10724995182899HistolockUS EndoscopyPRV2020-04-02
00849233001770Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-16
00849233001787Busse Hospital Disposables ROBERT BUSSE & CO., INC.PRV2016-09-16
00849233009967Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-15
00849233009943Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-13
00849233009950Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-13
00849233013803Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013834Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013278Busse Hospital Disposables ROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013285Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013292Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
10849233013831Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02
00849233013841Busse Hospital DisposablesROBERT BUSSE & CO., INC.PRV2016-09-02