D-SPOT

GUDID 00815137021343

General Imaging/Radiation Therapy Skin Markers, lead-free radiopaque arrow

Beekley Corporation

Radiographic image marker, manual
Primary Device ID00815137021343
NIH Device Record Key55218fb5-9a78-4f78-87f4-62a727eefd55
Commercial Distribution StatusIn Commercial Distribution
Brand NameD-SPOT
Version Model Number104S
Company DUNS001157841
Company NameBeekley Corporation
Device Count3
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815137021343 [Primary]
GS110815137020039 [Unit of Use]

FDA Product Code

JACSystem, X-Ray, Film Marking, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-30
Device Publish Date2019-07-22

On-Brand Devices [D-SPOT]

00815137021343General Imaging/Radiation Therapy Skin Markers, lead-free radiopaque arrow
00815137020032General Imaging/Radiation Therapy Skin Markers, lead-free radiopaque arrow

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