FDA.reportPublic FDA data

ReTAP(TM) Cardiovascular Patch

Primary DI
B042FG0005031
Brand
ReTAP(TM) Cardiovascular Patch
Company
SOLINAS MEDICAL INC.
Model
FG0005-03
Catalog number
FG0005-03
Device description
7mm ID x 4.5cm length x 230 degrees
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B042FG0005031PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, syntheticA sterile implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650.427.9835info@solinasmedical.com

Regulatory Flags#

DUNS number
962898792
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B042FG0005011ReTAP(TM) Cardiovascular PatchFG0005-01FG0005-012015-10-23
B042FG0005051ReTAP(TM) Cardiovascular PatchFG0005-05FG0005-052015-10-23
B042FG0005071ReTAP(TM) Cardiovascular PatchFG0005-07FG0005-072015-10-23
B042FG0005091ReTAP(TM) Cardiovascular PatchFG0005-09FG0005-092015-10-23
B042FG0008021ReTAP® Cardiovascular PatchFG0008-02FG0008-022016-12-01
B042FG0008041ReTAP® Cardiovascular PatchFG0008-04FG0008-042016-12-01
B042FG0008061ReTAP® Cardiovascular PatchFG0008-06FG0008-062016-12-01
B042FG0008081ReTAP® Cardiovascular PatchFG0008-08FG0008-082016-12-01
B042FG0008101ReTAP® Cardiovascular PatchFG0008-10FG0008-102016-12-01
B042FG0008211ReTAP® Cardiovascular PatchFG0008-21FG0008-212016-12-01
B042FG0008221ReTAP® Cardiovascular PatchFG0008-22FG0008-222016-12-01
B042FG0008231ReTAP® Cardiovascular PatchFG0008-23FG0008-232016-12-01
B042FG0008241ReTAP® Cardiovascular PatchFG0008-24FG0008-242016-12-01
B042FG0008251ReTAP® Cardiovascular PatchFG0008-25FG0008-252016-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888439624281CARDINAL HEALTHCardinal Health 200, LLCDXZ2019-12-16
14026704634504DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-21
14026704646750DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646767DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646781DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646798DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646804DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
10705031462212ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462229ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462281ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462304ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462335ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462359ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462366ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462373ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462403ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
00859389005102Tyke, Patch, Pledget and IntracardiacElutia Med LLCDXZ2019-02-28
14026704638540DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638557DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638564DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638571DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638588DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638601DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638618DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638625DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638632DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638649DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638656DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638663DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704634818DEKNATELTELEFLEX INCORPORATEDDXZ2018-07-30