FDA.reportPublic FDA data

exGraft

Primary DI
00818136022762
Brand
exGraft
Company
PECA LABS, INC.
Model
RGX051501
Catalog number
RUX051501
Device description
5mm ID x 15cm Length exGraft ePTFE Vascular Graft
Published
2024-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYFProsthesis, Vascular Graft, Of Less Then 6mm DiameterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183613000exGraft, exGraft CarbonPeca Labs2019-04-22DSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818136022762PackageGS11In Commercial Distribution
00818136022366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818136022762008181360227628181360227620818136022762
00818136022366008181360223668181360223660818136022366

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graftAn implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter
Lumen/Inner Diameter5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078340058
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818136020010exGraftRGX062501RUX0625012024-12-04
00818136020027exGraftRGX063501RUX0635012018-11-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00733132605354GORE ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606290GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606313GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606351GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606375GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606399GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132606436GORE PROPATEN Vascular Graft Pediatric ShuntW. L. Gore & Associates, Inc.DYF2017-02-13
00733132607068GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132607129GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132607143GORE PROPATEN Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132613960GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132613977GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132613984GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132613991GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614004GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614011GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614028GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614035GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614073GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614080GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614110GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614165GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132614172GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615872GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615889GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615926GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615933GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615940GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615957GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13
00733132615988GORE-TEX Vascular GraftW. L. Gore & Associates, Inc.DYF2017-02-13