HandCut

Basic Information

• Brand Name: HandCut
• Primary DI: 08056138586130
• Version / Model: PM14114
• Catalog Number: PM14114
• 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: d12cfc84-0826-40e1-9e78-cc48cb68b69d

Device Description

DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY WITH MANUAL ACTION 14G x 114 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
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18056138586137	GS1		10	In Commercial Distribution
Primary	08056138586130	GS1

Device Sizes

Type	Value	Unit	Text
Needle Gauge	14	Gauge
Length	114	Millimeter