PRONTO 4008

GUDID 30841156100258

Pronto V4, 8F

TELEFLEX INCORPORATED

Thrombectomy suction catheter

• Primary Device ID: 30841156100258
• NIH Device Record Key: 062ad34e-9e2b-47d3-a998-8da7cf1a9ab8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRONTO
• Version Model Number: IPN913533
• Catalog Number: 4008
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841156100254 [Primary]
GS1	30841156100258 [Package]; Contains: 10841156100254; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103405

FDA Product Code

• DXE: Catheter, embolectomy

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: 2022-08-05
• Device Publish Date: 2018-11-08

On-Brand Devices [PRONTO]

• 30841156100333: Pronto 035, 10F
• 20841156109001: PRONTO LP 5F
• 20841156108998: PRONTO LP 6F
• 20841156108981: PRONTO V4 6F
• 20841156108974: PRONTO V4 5.5F
• 20841156108967: PRONTO V3 6F
• 30841156100326: Pronto LP, 5F
• 30841156100319: Pronto LP, 6F
• 30841156100302: Pronto V3, 6F
• 30841156100258: Pronto V4, 8F
• 30841156100241: Pronto V4, 7F
• 30841156100234: Pronto V4, 6F
• 30841156100227: Pronto V4, 5.5F