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 |
| 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
| 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 |
| 00370275850106 - BioStom | 2024-02-22 BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precis |
| 00370275850250 - BioStom | 2024-02-22 BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precis |
| 00370275850502 - BioStom | 2024-02-22 BioStom Oral Pain Gel is a gel for the relief and management of oral pain. BioStom Oral Pain Gel is packaged in tubes for precis |
Trademark Results [OralID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORALID 87605183 5528222 Live/Registered |
Forward Science Holding, Inc. 2017-09-12 |
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