SCANLAN® In Situ Valvulotomes 9009-125

GUDID 00846159032000

Valvulotome

SCANLAN INTERNATIONAL INC

Valvulotome

• Primary Device ID: 00846159032000
• NIH Device Record Key: 87d19d7d-bd04-4890-b83c-f33c3e0c823f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCANLAN® In Situ Valvulotomes
• Version Model Number: 9009-125
• Catalog Number: 9009-125
• Company DUNS: 023055619
• Company Name: SCANLAN INTERNATIONAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 651-298-0997
• Email: vanderpoelw@scanlangroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846159032000 [Primary]

FDA Product Code

• MGZ: Valvulotome

Sterilization

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

[00846159032000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-02

On-Brand Devices [SCANLAN® In Situ Valvulotomes ]

• 00846159032000: Valvulotome
• 00846159031997: Valvulotome
• 00846159010992: Valvulotome
• 00846159010985: In Situ Valvulotome cutting edge
• 00846159010978: In Situ Valvulotome cutting edge