FDA.reportPublic FDA data

Busse Hospital Diposables

Primary DI
10849233004716
Brand
Busse Hospital Diposables
Company
ROBERT BUSSE & CO., INC.
Model
B1352
Catalog number
B1352
Device description
SS 3.5MM Pellet Insertion Tray with Large Gloves
Published
2020-07-16
Public version status
New
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
FBQTrocar, Gastro-Urology

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233004716PackageGS120In Commercial Distribution
00849233004719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923300471610849233004716
00849233004719008492330047198492330047190849233004719

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.

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
true
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
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
00849233014121Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-12-24
10849233014128Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-12-24
00849233014015Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-09-29
10849233014012Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-09-29
00849233013162Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-05-01
00849233013124Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-04-23
10849233013121Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-04-23
00849233012837Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-20
10849233012834Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-20
00849233012813Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-11
10849233012810Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-11
00849233012776Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-25
10849233012773Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-25
00849233012769Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-14
10849233012766Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-14
00849233012493Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
00849233012516Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
10849233012490Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
10849233012513Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2024-05-22
08964003163853Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163860Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163877Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163884Doctor NiceB. Ali ImpexFBQ2024-01-29
08964003163891Doctor NiceB. Ali ImpexFBQ2024-01-29
00849233011144Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-20
00849233011175Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
00849233011229Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
10849233011172Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
10849233011226Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
00849233011113Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-15