Mammotome elite

GUDID 10841911100864

Introducer Stylet

DEVICOR MEDICAL PRODUCTS, INC.

Side-notch biopsy gun handpiece/needle
Primary Device ID10841911100864
NIH Device Record Keyd29090c0-3bac-408b-9bce-24abe7921145
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome elite
Version Model NumberMEI10
Company DUNS961832156
Company NameDEVICOR MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Dimensions

Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge
Needle Gauge10 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911100867 [Primary]
GS110841911100864 [Package]
Contains: 00841911100867
Package: [5 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-14
Device Publish Date2022-02-04

On-Brand Devices [Mammotome elite]

10841911100895Probe
10841911100888Probe
00841911100850Holster (tetherless vacuum-assisted biopsy system)
10841911100871Introducer Stylet
10841911100864Introducer Stylet
00841911101703"Holster (tetherless vacuum-assisted biopsy system)"
00841911102823Holster (tetherless vacuum-assisted biopsy system)
10841911102806Probe
10841911102790Mammotome Elite Probe

Trademark Results [Mammotome elite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAMMOTOME ELITE
MAMMOTOME ELITE
85782899 4364699 Live/Registered
Devicor Medical Products, Inc.
2012-11-19
MAMMOTOME ELITE
MAMMOTOME ELITE
85320701 4203206 Live/Registered
Devicor Medical Products, Inc.
2011-05-13

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