FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
00849233015043
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
3580
Catalog number
3580
Device description
"77 x 108 Full Body Drape w/ 6"" SQ Fenestration "
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K843496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K843496000DRAPE SURGICAL UTILITY DRAPE STERILEBusse Hospital Disposables, Inc.1984-10-31KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233015040PackageGS110In Commercial Distribution
00849233015043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301504010849233015040
00849233015043008492330150438492330150430849233015043

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, sterileA sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. 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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00849233005129Busse Hospital DisposablesB1435B14352020-10-20
00849233014350Busse Hospital Disposables29112026-04-27
00849233014817Busse Hospital Disposables29602026-04-27
00849233000193Busse Hospital Disposables6007R16007R12016-09-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30193489017766MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017773MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017780MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
30193489017797MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-24
00380657530021ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
00380659983313ORA SYSTEM, VerifEyeAlcon Laboratories, Inc.PUI2026-07-22
B376KB100DAB0Drape KB100 SeriesKent Imaging IncPUI2026-07-21
10198956353954CARDINAL HEALTHCardinal Health 200, LLCPUI2026-07-20
20193489029939MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
20193489029953MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
30193489028199MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
06975424190771Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-07-16
16931918102214AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918102948AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918107356AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
20193489108214MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
20888277636559MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
00628110259448MolecuLightDX Sterile Surgical Sleeve Convenience Kit of 25MolecuLight IncKKX2026-07-08
00628110259554MolecuLightDX Eco DarkDrapes (Case of 50)MolecuLight IncPUI2026-07-08
00628110259578MolecuLightDX DarkDrape Eco ClipMolecuLight IncPUI2026-07-08
06932523052430Equipment DrapeJiangSu MedPlus Non-Woven Manufacturer Co., LtdPUI2026-07-08
10304040193362Henry ScheinHENRY SCHEIN, INC.PUI2026-06-25
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501289HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501296HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04