StimTrode
GUDID 00856817005680
AXELGAARD MANUFACTURING CO., LTD.
Transcutaneous electrical stimulation electrode| Primary Device ID | 00856817005680 |
| NIH Device Record Key | ece0bb42-fde4-476d-a83b-fd014c58a370 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StimTrode |
| Version Model Number | ST75D |
| Company DUNS | 150959401 |
| Company Name | AXELGAARD MANUFACTURING CO., LTD. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com | |
| Phone | 760-451-8000 |
| support@axelgaard.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856817005680 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132422
FDA Product Code
| GXY | Electrode, Cutaneous |
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 | 2016-03-31 |
On-Brand Devices [StimTrode]
| 00856817005727 | ST5010 |
| 00856817005710 | ST510D |
| 00856817005703 | ST5090 |
| 00856817005697 | ST5050 |
| 00856817005680 | ST75D |
| 00856817005673 | ST50D |
| 00856817005666 | ST32D |
| 00851913006135 | ST4065 |
Trademark Results [StimTrode]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STIMTRODE 88266315 not registered Live/Pending |
Axelgaard Manufacturing Co., Ltd. 2019-01-17 |
 STIMTRODE 74397175 not registered Dead/Abandoned |
AXELGAARD MANUFACTURING CO., LTD. 1993-06-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.