FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
10849233013831
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
988
Catalog number
988
Device description
Safety Deluxe bone Marrow Biopsy/Aspiration Tray with Snare-it marrow acquisition & Aspiration 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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy
PRVGastro-Urology Biopsy Kit

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110883000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110883000J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULABusse Hospital Disposables2011-06-08KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233013831PackageGS110In Commercial Distribution
00849233013834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301383110849233013831
00849233013834008492330138348492330138340849233013834

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 Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002418234
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

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
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08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
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06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636003CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
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06937278636027CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
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