Mammotome MR

GUDID 00841911101079

MR Targeting Set - Long

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system
Primary Device ID00841911101079
NIH Device Record Keyfb75b93a-3dd8-4903-bd6b-7fe7032c55ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome MR
Version Model NumberMRT11X
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

Device Dimensions

Needle Gauge11 Gauge
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge
Length145 Millimeter
Needle Gauge11 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911101079 [Primary]
GS110841911101076 [Package]
Package: [1 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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-25

On-Brand Devices [Mammotome MR]

00841911101116Universal Targeting Set - Long
00841911101109Universal Targeting Set - Short
00841911101093Universal Targeting Set - Long
00841911101086Universal Targeting Set - Short
00841911101079MR Targeting Set - Long
00841911101062MR Targeting Set - Short
00841911101055MR Targeting Set - Long
00841911101048MR Targeting Set - Short
00841911101031MR Bladeless Probe with Tube Set - Long
00841911101024MR Bladeless Probe with Tube Set - Short
00841911101017MR Bladeless Probe with Tube Set - Long
00841911101000MR Bladeless Probe with Tube Set - Short
00841911101321MR Biopsy Procedure Kit - Long with Targeting Set
00841911101314MR Biopsy Procedure Kit - Short with Targeting Set
00841911101307MR Biopsy Procedure Kit - Long with Targeting Set
00841911101291MR Biopsy Procedure Kit - Short with Targeting Set
00841911101369Universal Biopsy Procedure Kit - Long
00841911101352Universal Biopsy Procedure Kit - Short with Targeting Set
00841911101345Universal Biopsy Procedure Kit - Long with Targeting Set
00841911101338Universal Biopsy Procedure Kit - Short with Targeting Set
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