exGraft RUX053501

GUDID 00818136022786

5mm ID x 35cm Length exGraft ePTFE Vascular Graft

PECA LABS, INC.

Synthetic vascular graft

• Primary Device ID: 00818136022786
• NIH Device Record Key: 2a429922-3b07-47c8-8d6b-d619e6168aa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: exGraft
• Version Model Number: RGX053501
• Catalog Number: RUX053501
• 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: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter
• Length: 35 Centimeter
• Lumen/Inner Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818136022380 [Primary]
GS1	00818136022786 [Package]; Contains: 00818136022380; 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: 2019-08-06

On-Brand Devices [exGraft]

• 00818136021024: 10mm ID x 35cm length exGraft Carbon ePTFE Vascular Graft
• 00818136021147: 16mm ID x 35cm Length exGraft ePTFE Vascular Graft
• 00818136020584: 8mm ID X 35cm Length exGraft ePTFE Vascular Graft
• 00818136020546: 6mm ID X 35cm Length exGraft ePTFE Vascular Graft
• 00818136020980: 8mm ID X 35cm Length exGraft Carbon ePTFE Vascular Graft
• 00818136020621: 10mm ID x 35cm length exGraft ePTFE Vascular Graft
• 00818136023257: 19mm ID x 25cm L exGraft ePTFE Vascular Graft
• 00818136023226: 13mm ID x 35cm Length exGraft ePTFE Vascular Graft
• 00818136022786: 5mm ID x 35cm Length exGraft ePTFE Vascular Graft
• 00818136022748: 4mm ID x 35cm Length exGraft ePTFE vascular graft
• 00818136022700: 3.5mm ID x 35cm Length exGraft ePTFE vascular graft
• 00818136022663: 3mm ID x 35cm Length exGraft ePTFE Vascular Graft
• 00818136020461: 8mm ID X 35cm Length exGraft Carbon ePTFE Vascular Graft
• 00818136020775: 18mm ID x 25cm L exGraft ePTFE Vascular Graft
• 00818136020706: 14mm ID x 35cm L exGraft ePTFE Vascular Graft
• 00818136020669: 12mm ID x 35cm L exGraft ePTFE Vascular Graft
• 00818136020881: 24mm x 15cm exGraft ePTFE Vascular Graft
• 00818136020850: 22mm ID x 25cm L exGraft ePTFE Vascular Graft
• 00818136020812: 20mm ID x 25cm L exGraft ePTFE Vascular Graft