FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
10849233001463
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
1958
Device description
Horizon Health Care Services - Dressing Kit
Published
2022-07-20
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
MCYWound Dressing Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCYWound Dressing KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233001463PackageGS130In Commercial Distribution
00849233001466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923300146310849233001463
00849233001466008492330014668492330014660849233001466

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, medicated, sterileA collection of sterile instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. 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
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
00849233016538Busse Hospital Disposables40122026-05-21
00849233016958Busse Hospital Disposables40172026-05-21
00849233003750Busse Hospital DisposablesB1326B13262020-06-25
00849233003767Busse Hospital DisposablesB1328B13282020-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198459171789Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-11-24
10653160381518MEDLINEMEDLINE INDUSTRIES, INC.MCY2024-10-28
10198459057939Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-10-20
10195327657833Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
10195327667924Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2024-07-29
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10195327559182Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-12-21
10193489360479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCY2023-07-29
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