Mammotome Hydromark

GUDID 10841911102318

HydroMARK Breast Biopsy Site Marker

DEVICOR MEDICAL PRODUCTS, INC.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable
Primary Device ID10841911102318
NIH Device Record Key6422ca32-cff7-4c54-91ab-18a788f4bcb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMammotome Hydromark
Version Model Number4010-03-09-T3
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
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
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
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 Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge
Needle Gauge9 Gauge

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911102311 [Primary]
GS110841911102318 [Package]
Contains: 00841911102311
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEUMarker, Radiographic, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-16
Device Publish Date2022-02-08

On-Brand Devices [Mammotome Hydromark]

10841911102318HydroMARK Breast Biopsy Site Marker
10841911102301HydroMARK Breast Biopsy Site Marker
10841911102479HydroMARK Breast Biopsy Site Marker
10841911102462HydroMARK Breast Biopsy Site Marker
10841911102448HydroMARK Breast Biopsy Site Marker
10841911102431HydroMARK Breast Biopsy Site Marker
10841911102424HydroMARK Breast Biopsy Site Marker
10841911102394HydroMARK Breast Biopsy Site Marker
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