LumiMARK Breast Biopsy Site Marker

GUDID 00841911103004

Breast Biopsy Site Marker

DEVICOR MEDICAL PRODUCTS, INC.

Radiological image marker, implantable
Primary Device ID00841911103004
NIH Device Record Keyb6ef20ca-8189-4a23-9804-273bd1af1483
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumiMARK Breast Biopsy Site Marker
Version Model NumberLM0215R
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841911103004 [Primary]

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 Date2024-03-19
Device Publish Date2024-03-11

On-Brand Devices [LumiMARK Breast Biopsy Site Marker]

10841911103001LM0215R
10841911102998Breast Biopsy Site Marker
10841911102981Breast Biopsy Site Marker
00841911103004Breast Biopsy Site Marker
00841911102991LumiMARK Breast Biopsy Site Marker
00841911102984Breast Biopsy Site Marker

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