Mammotome MAMMOMARK 2

GUDID 10841911101656

Biopsy Site Identifier

DEVICOR MEDICAL PRODUCTS, INC.

Imaging lesion localization marker, implantable
Primary Device ID10841911101656
NIH Device Record Key0e5fa723-6d4e-4fec-99d5-03cbc23e0832
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome MAMMOMARK 2
Version Model NumberMAM3008
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
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
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
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge
Needle Gauge8 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911101659 [Primary]
GS110841911101656 [Package]
Contains: 00841911101659
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEUMarker, Radiographic, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-01

On-Brand Devices [Mammotome MAMMOMARK 2]

10841911101656Biopsy Site Identifier
10841911101649Biopsy Site Identifier
10841911100444Biopsy Site Identifier
10841911100437Biopsy Site Identifier

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