FDA.reportPublic FDA data

HAART Polyester Pledget 6-Pack

Primary DI
10857160006338
Brand
HAART Polyester Pledget 6-Pack
Company
Corcym Inc.
Model
100-06US
Catalog number
100-06US
Device description
Polyester pledgets for use with HAART Aortic Annuloplasty Devices
Published
2019-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
10857160006338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085716000633810857160006338

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
512-970-9112julie.thomas@biostable-s-e.com

Regulatory Flags#

DUNS number
112833663
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857160006314HAART301-00US301-00US2023-07-17
10857160006239HAART200-19US200-19US2017-09-27
10857160006246HAART200-21US200-21US2017-09-27
10857160006253HAART200-23US200-23US2017-09-27
10857160006260HAART200-25US200-25US2017-09-27
10857160006277HAART300-19US300-19US2017-05-15
10857160006284HAART300-21US300-21US2017-05-15
10857160006291HAART300-23US300-23US2017-05-15
10857160006307HAART300-25US300-25US2017-05-15

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