FastCutE

Basic Information

• Brand Name: FastCutE
• Primary DI: 08052440106745
• Version / Model: VE1410
• Catalog Number: VE1410
• Company Name: M.D.L. S.R.L.
• Labeler DUNS: 447228586
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-26
• Public Version: 2
• Public Version Date: 2021-05-27
• Public Version Status: Update
• Public Device Record Key: 0e8cc833-eeab-4055-b2da-2d8c7e0d528a
• Distribution End Date: 2021-04-26

Device Description

DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY 14G X 100 mm, COMPATIBLE AUTOMATIC PROMAG 2.2 ® GUN

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64327	End-cut biopsy gun needle	An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08052440106745	GS1