Faset

Basic Information

• Brand Name: Faset
• Primary DI: 08800039825283
• Version / Model: A
• Catalog Number: FA.IN.0002
• Company Name: DIOMEDICAL CO.,LTD.
• Labeler DUNS: 557795909
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-08
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 1a3405ff-c03c-4d4e-9508-b9a6b330849a

Device Description

V-Pin Needle Set_Single

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MRW	SYSTEM, FACET SCREW SPINAL DEVICE	Unknown		U

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
Primary	08800039825283	GS1

Customer Contacts

• Phone: [phone] ext. 112
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180729	000