FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
00849233009837
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
285
Catalog number
285
Device description
14MM Curved Curette
Published
2020-05-21
Public version status
New
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
HCYCurette, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCYCurette, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233009834PackageGS125In Commercial Distribution
00849233009837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923300983410849233009834
00849233009837008492330098378492330098370849233009837

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine curette, suctionA sterile, tubular, semi-rigid, hand-held device used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device typically has a rounded blunt nose and an opening(s) with a blunt scraping edge(s) at the distal end. It is connected at the proximal end to tubing and a suction source, typically an abortion suction system, which provides regulated suction. Also known as a pregnancy termination catheter, it is typically made of plastic and is available in various shapes and sizes. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
002418234
Device count
1
Premarket exempt
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

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Primary DI, Brand, Company table
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10195594752279CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-26
10195594758813CARDINAL HEALTHCardinal Health 200, LLCHCY2022-07-25
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