CoolTone CS-MS-002-D-00
GUDID 04053815076698
Zimmer MedizinSysteme GmbH
Deep-tissue electromagnetic stimulation system, professional| Primary Device ID | 04053815076698 |
| NIH Device Record Key | 1ef4c1a2-0acc-4c7e-aea5-d7c3fe6cd99e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoolTone |
| Version Model Number | 5034 |
| Catalog Number | CS-MS-002-D-00 |
| Company DUNS | 316111251 |
| Company Name | Zimmer MedizinSysteme GmbH |
| 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 | 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 | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04053815076698 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192940
FDA Product Code
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning |
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 | 2019-12-12 |
| Device Publish Date | 2019-12-04 |
Devices Manufactured by Zimmer MedizinSysteme GmbH
| 04053815088325 - Endolaser HP | 2025-03-25 |
| 04053815088332 - EndoPuls 811 | 2025-03-25 |
| 04053815087410 - ZStim | 2024-08-06 |
| 04053815086369 - ZShape | 2024-07-29 |
| 04053815087229 - Cryo 7 | 2024-06-04 |
| 04053815076711 - MFG-05 | 2023-10-24 |
| 04053815081296 - ThermoTK | 2023-06-13 |
| 04053815083344 - clTrac | 2023-06-13 |
Trademark Results [CoolTone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COOLTONE 98739920 not registered Live/Pending |
Sage Electrochromics, Inc. 2024-09-09 |
 COOLTONE 88266308 not registered Live/Pending |
Zeltiq Aesthetics, Inc. 2019-01-17 |
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