FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
00849233017276
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
4043
Device description
Custom Cath Pack
Published
2026-05-28
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
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233017273PackageGS110In Commercial Distribution
00849233017276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301727310849233017273
00849233017276008492330172768492330172760849233017276

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
631-425-4711mail@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
00849233003781Busse Hospital DisposablesB1330B13302020-07-10
00849233005112Busse Hospital DisposablesB1324B13242020-10-20
00849233011847Busse Hospital DisposablesB19302023-08-24
00849233018099Busse Hospital Disposables40422026-08-14
00849233017511Busse Hospital DisposablesB20862026-07-21
00849233017528Busse Hospital DisposablesB20282026-07-21
00849233017344Busse Hospital DisposablesB17122026-06-25
00849233017375Busse Hospital DisposablesB17132026-06-25
00849233014329Busse Hospital Disposables30342026-03-25
00849233017948Busse Hospital Disposables30922026-06-23
00849233013797Busse Hospital Disposables9792026-06-09
00849233010277Busse Hospital Disposables949794972020-04-02
00849233010376Busse Hospital Disposables954595452020-04-03
00849233004481Busse Hospital Disposables249124912016-09-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160532966HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532973HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532980HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532997HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533000HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533017HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533024HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533031HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533048HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533055HalyardAVID MEDICAL, INC.LRO2026-09-05
10198956333420CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956395947CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956462977CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956486058CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956530744CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956531611CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956535985CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956541177CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956541702CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956542532CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956546509CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956546585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956547285CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956548022CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956551763CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956552364CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956552401CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956553385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956554399CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956554429CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04