Mammotome

GUDID 00841911100614

Cart

DEVICOR MEDICAL PRODUCTS, INC.

Mammographic stereotactic biopsy system
Primary Device ID00841911100614
NIH Device Record Keyf6378bfd-850a-407e-b631-93a06864641c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome
Version Model NumberSCMC1
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 54 Degrees Celsius
Storage Environment TemperatureBetween -35 Degrees Celsius and 54 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911100614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-10

On-Brand Devices [Mammotome]

10841911101281DISPOSABLE DRAPE
10841911101229Vacuum Set
10841911100994Hand-Held Probe
10841911100987Hand-Held Probe
10841911100970Hand-Held Probe
10841911100963Hand-Held Probe
00841911100645Holster and Cable
00841911100638Software Package
00841911100621Cart Upgrade
00841911100614Cart
00841911100607Control Module with SmartVac
00841911100591Control Module with SmartVac
00841911100584Control Module MR Interlock System
00841911100577Holster with Keypad, Spool and Cable
00841911100560Remote Keypad
00841911100553Footswitch
00841911100546Holster and Cable
10841911101243Variable Aperture Sleeve
10841911101236Variable Aperture Sleeve
10841911101199Probe Guide
10841911101182Probe Guide
10841911101175Localization Guide
10841911101168Probe Guide
10841911101151Probe Guide
10841911101144Probe Guide
10841911101137Probe Guide
10841911101120Probe Guide
00841911101888Control Module MR Interlock System
00841911101765Footswitch
00841911101840Holster and Cable
00841911101833Software Package
00841911101826Cart Upgrade
00841911101819Cart
00841911101802Control Module with SmartVac
00841911101796Control Module with SmartVac

Trademark Results [Mammotome]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAMMOTOME
MAMMOTOME
74573480 1971904 Live/Registered
DEVICOR MEDICAL PRODUCTS, INC.
1994-09-14

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