FDA.reportPublic FDA data

Busse Hospital Disposables

Primary DI
10849233013138
Brand
Busse Hospital Disposables
Company
ROBERT BUSSE & CO., INC.
Model
549
Catalog number
549
Device description
E.R. Laceration Tray with Safety Components
Published
2020-05-07
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849233013138PackageGS120In Commercial Distribution
00849233013131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084923301313810849233013138
00849233013131008492330131318492330131310849233013131

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile 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
1 (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
10849233014319Busse Hospital Disposables30392026-02-02
10849233014159Busse Hospital Disposables29812025-12-29
10849233014197Busse Hospital Disposables29822025-12-29
10849233014289Busse Hospital Disposables30352025-12-29
10849233014296Busse Hospital Disposables30302025-12-29
10849233014302Busse Hospital Disposables30442025-12-29
10849233014128Busse Hospital DisposablesB11452025-12-24
10849233014111Busse Hospital Disposables29672025-12-17
10849233014142Busse Hospital Disposables29802025-12-17
10849233014234Busse Hospital Disposables29852025-11-18
10849233014012Busse Hospital DisposablesB11462025-09-29
10849233014043Busse Hospital Disposables29462025-09-25
10849233013572Busse Hospital Disposables8917R12025-06-23
10849233013497Busse Hospital Disposables28832025-05-06
00849233013162Busse Hospital DisposablesB84752025-05-01
10849233013121Busse Hospital DisposablesB84602025-04-23
10849233012834Busse Hospital DisposablesB17172025-03-20
10849233012827Busse Hospital Disposables28542025-03-12
10849233012810Busse Hospital DisposablesB17162025-03-11
10849233012780Busse Hospital Disposables28972025-03-04

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