Novatome

GUDID 00866215000057

SCHOLTEN SURGICAL INSTRUMENTS, INC.

Endomyocardial biopsy forceps, single-use

• Primary Device ID: 00866215000057
• NIH Device Record Key: 1cba6455-4ff9-48f3-80e4-59683e17341b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novatome
• Version Model Number: SU103-100
• Company DUNS: 130178346
• Company Name: SCHOLTEN SURGICAL INSTRUMENTS, 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: 866-452-3525
• Email: jimv@novatome.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866215000057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072051

FDA Product Code

• DWZ: Device, Biopsy, Endomyocardial

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-29
• Device Publish Date: 2016-09-06

On-Brand Devices [Novatome]

• 00866215000064: SU103-100PC
• 00866215000057: SU103-100
• 00866215000040: SU104-100
• 00866215000033: SU104-50
• 00866215000026: SU103-50
• 00866215000019: SU102-50
• 00866215000002: SU101-50