Mammotome MR

GUDID 00841911101000

MR Bladeless Probe with Tube Set - Short

DEVICOR MEDICAL PRODUCTS, INC.

Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle Side-notch biopsy gun handpiece/needle
Primary Device ID00841911101000
NIH Device Record Key55634480-13bd-4ef0-bb3d-11380fb648d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome MR
Version Model NumberMRP08S
Company DUNS961832156
Company NameDEVICOR MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com
Phone877-926-2666
Emailcustomersupport@mammotome.com

Device Dimensions

Needle Gauge8 Gauge
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge
Length115 Millimeter
Needle Gauge8 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911101000 [Primary]
GS110841911101007 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-12
Device Publish Date2016-10-25

On-Brand Devices [Mammotome MR]

00841911101116Universal Targeting Set - Long
00841911101109Universal Targeting Set - Short
00841911101093Universal Targeting Set - Long
00841911101086Universal Targeting Set - Short
00841911101079MR Targeting Set - Long
00841911101062MR Targeting Set - Short
00841911101055MR Targeting Set - Long
00841911101048MR Targeting Set - Short
00841911101031MR Bladeless Probe with Tube Set - Long
00841911101024MR Bladeless Probe with Tube Set - Short
00841911101017MR Bladeless Probe with Tube Set - Long
00841911101000MR Bladeless Probe with Tube Set - Short
00841911101321MR Biopsy Procedure Kit - Long with Targeting Set
00841911101314MR Biopsy Procedure Kit - Short with Targeting Set
00841911101307MR Biopsy Procedure Kit - Long with Targeting Set
00841911101291MR Biopsy Procedure Kit - Short with Targeting Set
00841911101369Universal Biopsy Procedure Kit - Long
00841911101352Universal Biopsy Procedure Kit - Short with Targeting Set
00841911101345Universal Biopsy Procedure Kit - Long with Targeting Set
00841911101338Universal Biopsy Procedure Kit - Short with Targeting Set

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