Saltillo NC8.4-15

GUDID 00816486021091

NovaChat 8.4 Keyguard 15 location

PRENTKE ROMICH COMPANY

Voice synthesizer/digitizer

• Primary Device ID: 00816486021091
• NIH Device Record Key: 4ad00d39-d5b4-477e-9a0c-89b406c9db4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saltillo
• Version Model Number: 19254-15
• Catalog Number: NC8.4-15
• Company DUNS: 080143399
• Company Name: PRENTKE ROMICH COMPANY
• 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: false
• Serial Number: false
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com
• Phone: 9999999999
• Email: acc@saltillo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816486021091 [Primary]

FDA Product Code

• ILQ: System, Communication, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-29
• Device Publish Date: 2020-10-21

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