SilveRest™ A10009-100

GUDID 50813150020584

GRAPHIC CONTROLS ACQUISITION CORP

Electrocardiographic electrode, single-use

• Primary Device ID: 50813150020584
• NIH Device Record Key: e8bf5abe-b538-4e6b-8991-4005ca07bf65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SilveRest™
• Version Model Number: A10009-100
• Catalog Number: A10009-100
• Company DUNS: 002111896
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Device Count: 100
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.800.669.6905
• Email: customerservice@vermed.com
• Phone: 1.800.669.6905
• Email: customerservice@vermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813150020589 [Unit of Use]
GS1	40813150020587 [Primary]
GS1	50813150020584 [Package]; Contains: 40813150020587; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [SilveRest™]

• 60813150021335: A10201-500
• 60813150020734: A10023-10
• 50813150020584: A10009-100
• 10009336008459: Resting ECG TAB Electrodes