OralID

GUDID 00370275123163

OralID is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer.

Forward Science Technologies LLC

Oral lesion examination light

• Primary Device ID: 00370275123163
• NIH Device Record Key: 0632d2a9-8e31-46a7-9f2b-ca42f1e165f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OralID
• Version Model Number: FS-11
• Company DUNS: 079212068
• Company Name: Forward Science Technologies LLC
• 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: 855-696-7254
• Email: info@forwardscience.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370275123163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123169

FDA Product Code

• NXV: Diagnostic Light, Soft Tissue Detector

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: 2016-10-03

Devices Manufactured by Forward Science Technologies LLC

• 00370275123088 - OralID Fitted Glasses: 2025-01-30 The OralID Fitted Glasses are designed as an accessory for use with the OralID device. These fitted glasses feature a filter tha
• 00370275123705 - OralID Over Glasses: 2025-01-30 The OralID Over Glasses are designed as an accessory for use with the OralID device. These over glasses feature a filter that en
• 00370275092025 - FS Dispenser, Stainless: 2024-10-22 The Stainless FS Dispenser is a hand-held syringe-like device that has a ring-handled plunger, a barrel with finger grips, and a
• 00370275713050 - Orapeutic: 2024-04-16 Orapeutic is an oral hydrogel wound dressing that is applied to wounds / ulcers in the oral cavity for the management of oral pa
• 00370275091011 - FS Dispenser: 2024-02-29 The FS Dispenser is intended for use in dispensing PerioStom. It will be provided non-sterile and is not intended to be steriliz
• 00037027571305 - Orapeutic: 2024-02-22 Orapeutic is an oral hydrogel wound dressing that is applied to wounds / ulcers in the oral cavity for the management of oral pa
• 00370275090168 - PerioStom: 2024-02-22 PerioStom Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tiss
• 00370275629047 - SalivaMAX: 2024-02-22 SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a solution with a high concentratio