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

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
00849233003774Busse Hospital DisposablesB1329B13292020-06-25
00849233012066Busse Hospital Disposables975497542020-04-08
00849233012691Busse Hospital Disposables27432024-09-13
00849233014053Busse Hospital Disposables30152025-10-01
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
00849233017276Busse Hospital Disposables40432026-05-28
00849233015906Busse Hospital DisposablesB84822026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849233006874Busse Hospital DisposablesROBERT BUSSE & CO., INC.FHC2022-04-08