OsteoJ

Basic Information

• Brand Name: OsteoJ
• Primary DI: 08056138585966
• Version / Model: PJ0815
• Catalog Number: PJ0815
• Company Name: M.D.L. S.R.L.
• Labeler DUNS: 447228586
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-14
• Public Version: 2
• Public Version Date: 2021-05-27
• Public Version Status: Update
• Public Device Record Key: 4b92d352-0955-486d-a49b-299240e08431

Device Description

DISPOSABLE BONE MARROW BIOPSY NEEDLE WITH EXTRACTION WIRE AND SAFETY 8G x 150 mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46350	Bone marrow biopsy needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18056138585963	GS1		10	In Commercial Distribution
Primary	08056138585966	GS1

Device Sizes

Type	Value	Unit	Text
Length	150	Millimeter
Needle Gauge	8	Gauge