exGraft Carbon RUC043501

GUDID 00818136022946

4mm ID x 35cm Length exGraft Carbon ePTFE Vascular Graft

PECA LABS, INC.

Synthetic vascular graft

• Primary Device ID: 00818136022946
• NIH Device Record Key: f17d549b-6c94-4fe1-9392-b5d8d7e20347
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: exGraft Carbon
• Version Model Number: RGC043501
• Catalog Number: RUC043501
• Company DUNS: 078340058
• Company Name: PECA LABS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818136022540 [Primary]
GS1	00818136022946 [Package]; Contains: 00818136022540; Package: Outer/Shipper Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183613

FDA Product Code

• DSY: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-17
• Device Publish Date: 2019-08-22

On-Brand Devices [exGraft Carbon]

• 00818136022984: 5mm ID x 35cm Length exGraft Carbon ePTFE Vascular Graft
• 00818136022946: 4mm ID x 35cm Length exGraft Carbon ePTFE Vascular Graft