FDA.reportPublic FDA data

exGraft

Primary DI
00818136020027
Brand
exGraft
Company
PECA LABS, INC.
Model
RGX063501
Catalog number
RUX063501
Device description
6mm ID X 35cm Length exGraft ePTFE Vascular Graft
Published
2018-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSYProsthesis, Vascular Graft, Of 6mm And Greater DiameterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818136020546PackageGS11In Commercial Distribution
00818136020027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818136020546008181360205468181360205460818136020546
00818136020027008181360200278181360200270818136020027

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graft, non-medicatedAn implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Centimeter
Lumen/Inner Diameter6Millimeter

Regulatory Flags#

DUNS number
078340058
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818136020010exGraftRGX062501RUX0625012024-12-04
00818136020041exGraftRGX081501RUX0815012024-12-04
00818136020058exGraftRGX082501RUX0825012024-12-04
00818136020065exGraftRGX083501RUX0835012018-11-16
00818136020089exGraftRGX101501RUX1015012024-12-04
00818136020096exGraftRGX102501RUX1025012024-12-04
00818136020102exGraftRGX103501RUX1035012019-04-26
00818136020126exGraftRGX121501RUX1215012024-12-04
00818136020133exGraftRGX122501RUX1225012024-12-04
00818136020140exGraftRGX123501RUX1235012020-02-25
00818136020164exGraftRGX141501RUX1415012024-12-04
00818136020171exGraftRGX142501RUX1425012024-12-04
00818136020188exGraftRGX143501RUX1435012020-02-25
00818136020201exGraftRGX161501RUX1615012024-12-04
00818136020218exGraftRGX162501RUX1625012024-12-04
00818136020225exGraftRGX163501RUX1635012018-11-16
00818136020249exGraftRGX181501RUX1815012024-12-04
00818136020256exGraftRGX182501RUX1825012020-02-25
00818136020287exGraftRGX201501RUX2015012024-12-04
00818136020294exGraftRGX2025012021-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00733132600038GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600052GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600076GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132600090GORE Hybrid Vascular Graft-CBASW. L. Gore & Associates, Inc.DSY2017-02-13
00733132605354GORE ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607068GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607129GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607143GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607150GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607174GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607181GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607211GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607228GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607235GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607242GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607259GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607266GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607273GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607280GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607297GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132607303GORE INTERING Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611508GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611539GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13
00733132611546GORE-TEX Stretch Vascular GraftW. L. Gore & Associates, Inc.DSY2017-02-13