Titan Medical
GUDID 80092237615900
Titan Hybrid - Private Labeled
COMPASS HEALTH BRANDS CORP.
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 80092237615900 |
| NIH Device Record Key | 7dc87a40-a463-474f-bdba-bb1fad2baff6 |
| Commercial Distribution Discontinuation | 2016-10-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Titan Medical |
| Version Model Number | DI3315 |
| Company DUNS | 827221698 |
| Company Name | COMPASS HEALTH BRANDS CORP. |
| 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 | true |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00092237615904 [Primary] |
| GS1 | 80092237615900 [Package] Contains: 00092237615904 Package: CA [32 Units] Discontinued: 2016-10-17 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100117
FDA Product Code
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-10-12 |
On-Brand Devices [Titan Medical]
| 80092237615900 | Titan Hybrid - Private Labeled |
| 80092237615894 | Titan 10 - Private Labeled |
Trademark Results [Titan Medical]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TITAN MEDICAL 90573147 not registered Live/Pending |
Titan Medical Inc. 2021-03-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.