BARD® MONOPTY®

Basic Information

• Brand Name: BARD® MONOPTY®
• Primary DI: 00801741084782
• Version / Model: 212016
• Catalog Number: 212016
• Company Name: Bard Peripheral Vascular, Inc.
• Labeler DUNS: 135057938
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: 92133bd8-720e-4a30-a347-53dd0513a1a8

Device Description

BARD® MONOPTY® Disposable Core Biopsy Instrument, 11mm penetration depth, 20g x 15cm

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
KNW	INSTRUMENT, BIOPSY	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58990	Side-notch biopsy gun handpiece/needle	A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10801741084789	GS1	CA	10	In Commercial Distribution
Primary	00801741084782	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	15	Centimeter
Needle Gauge	20	Gauge
Device Size Text, specify			Penetration Depth, 11 Millimeters