Mammotome EX

GUDID 10841911100956

Probe and Vacuum Set

DEVICOR MEDICAL PRODUCTS, INC.

Side-notch biopsy gun handpiece/needle
Primary Device ID10841911100956
NIH Device Record Key4366d6ac-14ed-4d30-beec-f33444cbb2f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome EX
Version Model NumberHH8BEX
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 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

Device Dimensions

Needle Gauge8 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911100959 [Primary]
GS110841911100956 [Package]
Contains: 00841911100959
Package: [5 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 Number4
Public Version Date2019-07-12
Device Publish Date2016-10-24

On-Brand Devices [Mammotome EX]

10841911100956Probe and Vacuum Set
10841911100949Probe and Vacuum Set

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