Eze-Sit Valvulotome TIVK2030

GUDID 00840663102297

Eze-Sit Valvulotome 94cm

Lemaitre Vascular, Inc.

Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous Valvulotome, percutaneous

• Primary Device ID: 00840663102297
• NIH Device Record Key: f99edcc0-b09b-4679-bd58-35b2c1deef3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eze-Sit Valvulotome
• Version Model Number: 94cm
• Catalog Number: TIVK2030
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Dimensions

• Shaft Length: 94 Centimeter
• Shaft Length: 94 Centimeter
• Shaft Length: 94 Centimeter
• Shaft Length: 94 Centimeter
• Shaft Length: 94 Centimeter
• Shaft Length: 94 Centimeter
• Shaft Length: 94 Centimeter
• Shaft Length: 94 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663102297 [Primary]

FDA Product Code

• MGZ: Valvulotome

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-08
• Device Publish Date: 2022-06-30

Devices Manufactured by Lemaitre Vascular, Inc.

• 00840663102297 - Eze-Sit Valvulotome: 2022-07-08Eze-Sit Valvulotome 94cm
• 00840663102297 - Eze-Sit Valvulotome: 2022-07-08 Eze-Sit Valvulotome 94cm
• 00840663108718 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 12cm x 25cm
• 00840663108787 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 2.5cm x 15cm
• 00840663108794 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 5cm x 10cm
• 00840663108800 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 12cm x 25cm
• 00840663108824 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 5cm x 10cm, eIFU
• 00840663108831 - XenoSure Biologic Patch: 2021-06-28 XenoSure Biologic Patch, 2.5cm x 15cm, eIFU
• 00840663108916 - YES Tape: 2021-06-28 YES Tape