GelShot

GUDID 20853904006296

METRON 5CM US ADAPTOR, Case of 10

Compass Richmar, LLC

Coupling gel disk holder
Primary Device ID20853904006296
NIH Device Record Key09989bfa-93b0-4c03-95f1-c1947784c790
Commercial Distribution Discontinuation2019-09-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGelShot
Version Model NumberGSA5MT1
Company DUNS080930531
Company NameCompass Richmar, LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone1-888-549-4945
Emailcustomerservice@richmarweb.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com

Device Identifiers

Device Issuing AgencyDevice ID
GS120853904006296 [Primary]

FDA Product Code

MUIMedia,Coupling,Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-27
Device Publish Date2016-11-23

On-Brand Devices [GelShot]

00853904006407GelShot-/Adaptor-Chattanooga Intelect Intelect Advanced, Vectra Genisys, Intelect Mobile or Inte
00853904006391GelShot-/Adaptor-Chattanooga Intelect Legend 5 cm
00853904006384GelShot-/Adaptor-Richmar 10 cm
00853904006377GelShot-/Adaptor-Richmar 5 cm
00853904006360GelShot Coupling Disks-5 cm2
00853904006353GelShot coupling disks-10 cm2
00853904006346GelShot coupling disks-2cm2
00853904006315AutoGel Pads-(50x)
00853904006292RICHMAR WINNER EVO 5CM US ADAPTOR
00850958007640RICHMAR WINNER EVO 10CM US ADAPTOR
00850958007602Chattanooga Intelect XT 5cm Sample Kit- French
00850958007596Metron 5cm Sample Kit- English
00850958007589Richmar 2cm Sample Kit- English
00850958007572Richmar 2cm Patterson Sample Kit- English
00850958007565Chattanooga Intelect XT 2cm Sample Kit- English
00850958007558Richmar 5cm Sample Kit- English
00850958007541Chattanooga Intelect XT 5cm Patterson Sample Kit- English
00850958007534Chattanooga Intelect XT 5cm Sample Kit- English
00850958007527Chattanooga Intelect XT 5cm Sample Kit - French & German
00850958007152CHATTANOOGA INTELECT ADVANCED, GENISYS, XT, OR INTELECT MOBILE, INTELECT TRANSPORT 2CM US ADAPTO
00850958007145CHATTANOOGA INTELECT ADVANCED, GENISYS, XT, OR INTELECT MOBILE, INTELECT TRANSPORT 10CM US ADAPT
00850958007138DYNATRON SOLARIS PLUS 709 (D719), SOLARIS PLUS 708 (D718), AND DYNATRON 25 SERIES COMBO UNITS (D
00850958007121METRON 5CM US ADAPTOR
00850958007114RICHMAR WINNER EVO 2CM US ADAPTOR
20853904006296METRON 5CM US ADAPTOR, Case of 10
10853904006404GelShot-/Adaptor-Chattanooga Intelect Intelect Advanced, Vectra Genisys, Intelect Mobile or Inte
10853904006299RICHMAR WINNER EVO 5CM US ADAPTOR, Case of 10
10850958007647RICHMAR WINNER EVO 10CM US ADAPTOR, Case of 10
10850958007142CHATTANOOGA INTELECT ADVANCED, GENISYS, XT, OR INTELECT MOBILE, INTELECT TRANSPORT 10CM US ADAPT
10850958007135DYNATRON SOLARIS PLUS 709 (D719), SOLARIS PLUS 708 (D718), AND DYNATRON 25 SERIES COMBO UNITS (D
10850958007111RICHMAR WINNER EVO 2CM US ADAPTOR, CASE OF 10
10853904006398GelShot-/Adaptor-Chattanooga Intelect Legend 5 cm, Case of 10
10850958007159CHATTANOOGA INTELECT ADVANCED, GENISYS, XT, OR INTELECT MOBILE, INTELECT TRANSPORT 2CM US ADAPTO

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.