ReTAP(TM) Cardiovascular Patch FG0005-01

GUDID B042FG0005011

6mm ID x 4.5cm length x 230 degrees

SOLINAS MEDICAL INC.

Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic Cardiovascular patch, synthetic
Primary Device IDB042FG0005011
NIH Device Record Key17438880-047d-48ee-8b82-c22387c09cc1
Commercial Distribution StatusIn Commercial Distribution
Brand NameReTAP(TM) Cardiovascular Patch
Version Model NumberFG0005-01
Catalog NumberFG0005-01
Company DUNS962898792
Company NameSOLINAS MEDICAL 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

Phone650.427.9835
Emailinfo@solinasmedical.com
Phone650.427.9835
Emailinfo@solinasmedical.com
Phone650.427.9835
Emailinfo@solinasmedical.com
Phone650.427.9835
Emailinfo@solinasmedical.com
Phone650.427.9835
Emailinfo@solinasmedical.com
Phone650.427.9835
Emailinfo@solinasmedical.com
Phone650.427.9835
Emailinfo@solinasmedical.com
Phone650.427.9835
Emailinfo@solinasmedical.com
Phone650.427.9835
Emailinfo@solinasmedical.com
Phone650.427.9835
Emailinfo@solinasmedical.com
Phone650.427.9835
Emailinfo@solinasmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB042FG0005011 [Primary]

FDA Product Code

DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-23

On-Brand Devices [ReTAP(TM) Cardiovascular Patch]

B042FG000509110mm ID x 4.5cm length x 230 degrees
B042FG00050719mm ID x 4.5cm length x 230 degrees
B042FG00050518mm ID x 4.5cm length x 230 degrees
B042FG00050317mm ID x 4.5cm length x 230 degrees
B042FG00050116mm ID x 4.5cm length x 230 degrees

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