Mammotome MammoTest

GUDID 00841911100539

Stereotactic Adapter

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 ID00841911100539
NIH Device Record Key5afcbd92-6d1e-460b-a161-d736b9b7a134
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome MammoTest
Version Model NumberB1021
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
GS100841911100539 [Primary]

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 Number5
Public Version Date2019-12-23
Device Publish Date2016-11-10

On-Brand Devices [Mammotome MammoTest]

00841911101581Stereotactic X-Ray Breast Biopsy Table System
00841911101215Probe Guide Holder Lateral
00841911101758Fischer Probe Guide Holder
00841911100539Stereotactic Adapter

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