Busse Hospital Disposables

Basic Information

• Brand Name: Busse Hospital Disposables
• Primary DI: 00849233013261
• Version / Model: 653
• Catalog Number: 653
• Company Name: ROBERT BUSSE & CO., INC.
• Labeler DUNS: 002418234
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 4
• Public Version Date: 2020-11-24
• Public Version Status: Update
• Public Device Record Key: 2a536246-7e17-4f88-87ca-bfecc7a8e49c

Device Description

Bone Marrow Biopsy/Aspiration Tray w/ Biopsy Needle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PRV	Gastro-Urology Biopsy Kit	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16833	Bone marrow biopsy procedure kit	A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10849233013268	GS1		10	In Commercial Distribution
Primary	00849233013261	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius