Herbst Telescopic Classic

GUDID 00851826007076

Oral Device For The Treatment Of Obstructive Sleep Apnea.

SOMNOMED, INC.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00851826007076
• NIH Device Record Key: b97f2131-ee02-4ecb-94b3-31faf3068ad3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Herbst Telescopic Classic
• Version Model Number: H1000
• Company DUNS: 623527962
• Company Name: SOMNOMED, 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: false
• Lot Batch: false
• Serial Number: true
• 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: 888-447-6673
• Email: customerservice@somnomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851826007076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130558

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-14

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