FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
10849233006871
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
2002
Device description
Biopsy Tray
Published
2022-04-08
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
FHCAdaptor To The Cord, For Transurethral Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHCAdaptor To The Cord, For Transurethral Surgical InstrumentGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233006871PackageGS110In Commercial Distribution
00849233006874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923300687110849233006871
00849233006874008492330068748492330068740849233006874

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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
00849233006874Busse Hospital DisposablesROBERT BUSSE & CO., INC.FHC2022-04-08