exGraft

Basic Information

• Brand Name: exGraft
• Primary DI: 00818136022335
• Version / Model: RGX042501
• Catalog Number: RUX042501
• Company Name: PECA LABS, INC.
• Labeler DUNS: 078340058
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-04
• Public Version: 3
• Public Version Date: 2025-12-25
• Public Version Status: Update
• Public Device Record Key: cfd2af84-fe67-4dd7-ac96-1890d8876ecb

Device Description

4mm ID x 25cm Length exGraft ePTFE vascular graft

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYF	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter	Cardiovascular	870.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35281	Synthetic vascular graft, non-medicated	An 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).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00818136022731	GS1	Outer/ Shipper Box	1	In Commercial Distribution
Primary	00818136022335	GS1

Device Sizes

Type	Value	Unit	Text
Length	25	Centimeter
Lumen/Inner Diameter	4	Millimeter