FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
00108492331975
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
B8123R1
Catalog number
B8123R1
Device description
SS 4.5MM Pellet Insertion Lg PVP Tray
Published
2020-04-08
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
00108492331975PackageGS120In Commercial Distribution
00849233001978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00108492331975001084923319751084923319750108492331975
00849233001978008492330019788492330019780849233001978

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
10849233014319Busse Hospital Disposables30392026-02-02
10849233014159Busse Hospital Disposables29812025-12-29
10849233014197Busse Hospital Disposables29822025-12-29
10849233014289Busse Hospital Disposables30352025-12-29
10849233014296Busse Hospital Disposables30302025-12-29
10849233014302Busse Hospital Disposables30442025-12-29
10849233014128Busse Hospital DisposablesB11452025-12-24
10849233014111Busse Hospital Disposables29672025-12-17
10849233014142Busse Hospital Disposables29802025-12-17
10849233014234Busse Hospital Disposables29852025-11-18
10849233014012Busse Hospital DisposablesB11462025-09-29
10849233014043Busse Hospital Disposables29462025-09-25
10849233013572Busse Hospital Disposables8917R12025-06-23
10849233013497Busse Hospital Disposables28832025-05-06
00849233013162Busse Hospital DisposablesB84752025-05-01
10849233013121Busse Hospital DisposablesB84602025-04-23
10849233012834Busse Hospital DisposablesB17172025-03-20
10849233012827Busse Hospital Disposables28542025-03-12
10849233012810Busse Hospital DisposablesB17162025-03-11
10849233012780Busse Hospital Disposables28972025-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10849233014128Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-12-24
10849233014012Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-09-29
00849233013162Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-05-01
10849233013121Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-04-23
10849233012834Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-20
10849233012810Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-03-11
10849233012773Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-25
10849233012766Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2025-02-14
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
10849233011172Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
10849233011226Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-16
10849233011110Busse Hospital DisposablesROBERT BUSSE & CO., INC.FBQ2023-11-15
08964003163075Doctor NiceB. Ali ImpexFBQ2023-11-10
08964003163112Doctor NiceB. Ali ImpexFBQ2023-11-10
08964003163129Doctor NiceB. Ali ImpexFBQ2023-11-10
08964003163136Doctor NiceB. Ali ImpexFBQ2023-11-10
08964003163143Doctor NiceB. Ali ImpexFBQ2023-11-10
08964003163020Doctor NiceB. Ali ImpexFBQ2023-11-09
08964003163037Doctor NiceB. Ali ImpexFBQ2023-11-09
08964003163051Doctor NiceB. Ali ImpexFBQ2023-11-09
08964003163068Doctor NiceB. Ali ImpexFBQ2023-11-09
08964003163082Doctor NiceB. Ali ImpexFBQ2023-11-09
08964003163099Doctor NiceB. Ali ImpexFBQ2023-11-09