Mammotome revolve MammoMark

GUDID 10841911100529

Biopsy Site Identifier

DEVICOR MEDICAL PRODUCTS, INC.

Imaging lesion localization marker, implantable
Primary Device ID10841911100529
NIH Device Record Key38b82cbe-8bfd-4a76-a73d-6d5479bd030f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome revolve MammoMark
Version Model NumberMMK1003
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

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
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
GS100841911100522 [Primary]
GS110841911100529 [Package]
Contains: 00841911100522
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 revolve MammoMark]

10841911101632Biopsy Site Identifier
10841911101625Biopsy Site Identifier
10841911101618Biopsy Site Identifier
00841911101604Biopsy Site Identifier
10841911101373Biopsy Site Identifier
10841911100529Biopsy Site Identifier
10841911100512Biopsy Site Identifier
10841911100499Biopsy Site Identifier
10841911100482Biopsy Site Identifier
10841911100475Biopsy Site Identifier

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