FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
00849233016996
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
B7345
Catalog number
B7345
Device description
3.2MM PELLET INSERTION TRAY
Published
2016-09-23
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
DRCTrocar
FBQTrocar, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2
FBQTrocar, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233016993PackageGS110In Commercial Distribution
00849233016996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301699310849233016993
00849233016996008492330169968492330169960849233016996

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 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
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
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
00849233014329Busse Hospital Disposables30342026-03-25
00849233015005Busse Hospital Disposables30892026-03-25
00849233009981Busse Hospital Disposables8208202019-03-26
00849233010017BUSSE HOSPITAL DISPOSABLES8228222019-03-26
00849233009974Busse Hospital Disposables8188182018-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731135391Redemption VILEX LLCDRC2026-01-12
00849233013124Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-04-23
00849233012837Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-20
00849233012813Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-11
00849233012776Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-25
00849233012769Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-14
10192253057218ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057225ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057232ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057249ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057256ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057263ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057287ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253065237ArgyleCardinal Health 200, LLCDRC2024-08-02
00849233012493Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
00849233012516Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
10884450412708Merit Advance®Merit Medical Systems, Inc.DRC2024-03-29
00849233011175Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
00849233011229Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
00849233011113Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-15
00849233011847Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-08-24
00849233012233Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-08-24
00849233010963Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-05-23
00849233010970Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-05-23
00849233010932Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-04-20
00849233006911Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2022-08-29
00849233006928Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2022-07-21
00849233005419Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2022-06-29
00849233003590Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2022-06-23
00849233006447Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2021-11-04