Hydro LeMaitre Valvulotome e1010-00

GUDID 00840663106837

Hydro LeMaitre Valvulotome (40 cm), eIFU

LEMAITRE VASCULAR, INC.

Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome Valvulotome

• Primary Device ID: 00840663106837
• NIH Device Record Key: 2c3002d1-9b7e-4eee-a580-50334f655095
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydro LeMaitre Valvulotome
• Version Model Number: e1010-00
• Catalog Number: e1010-00
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663106837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140042

FDA Product Code

• MGZ: Valvulotome

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-15

On-Brand Devices [Hydro LeMaitre Valvulotome]

• 00840663106837: Hydro LeMaitre Valvulotome (40 cm), eIFU
• 00840663106820: Hydro LeMaitre Valvulotome (98 cm), eIFU
• 00840663106660: 1.5mm HYDRO LeMaitre Valvulotome (40 cm)
• 00840663106653: 1.5mm HYDRO LeMaitre Valvulotome (98 cm)