Mammotome MammoTest

GUDID 00841911101215

Probe Guide Holder Lateral

DEVICOR MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable Needle guide, reusable
Primary Device ID00841911101215
NIH Device Record Keya67eb924-6594-4d23-ba25-d8bfe10c71f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome MammoTest
Version Model NumberG1621L
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911101215 [Primary]
GS100841911101727 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-12-23
Device Publish Date2016-11-10

On-Brand Devices [Mammotome MammoTest]

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