Mammotome MR

Basic Information

• Brand Name: Mammotome MR
• Primary DI: 00841911101017
• Version / Model: MRP08X
• Company Name: DEVICOR MEDICAL PRODUCTS, INC.
• Labeler DUNS: 961832156
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-25
• Public Version: 5
• Public Version Date: 2022-02-07
• Public Version Status: Update
• Public Device Record Key: 78bd7a07-6ebf-4275-8942-30d78fcee9a2

Device Description

MR Bladeless Probe with Tube Set - Long

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 Conditional
• 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
Primary	00841911101017	GS1
Package	10841911101014	GS1		1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042753	000

Device Sizes

Type	Value	Unit	Text
Length	145	Millimeter
Needle Gauge	8	Gauge