Pruitt Aortic Occlusion Catheter e2100-12

GUDID 00840663101528

Pruitt Aortic Occlusion Catheter, 12F, eIFU

LEMAITRE VASCULAR, INC.

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00840663101528
• NIH Device Record Key: 78bc79fb-aa35-46ee-9bcc-6ba880257516
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pruitt Aortic Occlusion Catheter
• Version Model Number: e2100-12
• Catalog Number: e2100-12
• Company DUNS: 184805166
• Company Name: LEMAITRE VASCULAR, INC.
• 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: 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx
• Phone: 781-221-2266
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663101528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872090

FDA Product Code

• DQT: Occluder, Catheter Tip

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-06-30

On-Brand Devices [Pruitt Aortic Occlusion Catheter]

• 00840663101528: Pruitt Aortic Occlusion Catheter, 12F, eIFU
• 00840663101511: Pruitt Aortic Occlusion Catheter, 12F