TetraSens SEN 2002
GUDID 07350012440039
TetraSens TetraGraph Electrode
Senzime AB (Publ.)
Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system Block-monitoring peripheral nerve electrical stimulation system| Primary Device ID | 07350012440039 |
| NIH Device Record Key | 9efb9cdb-7124-4fa4-8993-61ef30caa484 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TetraSens |
| Version Model Number | TetraSens |
| Catalog Number | SEN 2002 |
| Company DUNS | 559976316 |
| Company Name | Senzime AB (Publ.) |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 2399204288 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com | |
| Phone | 800-213-1324 |
| info.us@senzime.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350012440022 [Primary] |
| GS1 | 07350012440039 [Package] Contains: 07350012440022 Package: Box [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190795
FDA Product Code
| KOI | Stimulator, Nerve, Peripheral, Electric |
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 | 2020-05-01 |
| Device Publish Date | 2020-04-23 |
On-Brand Devices [TetraSens]
| 07350012440039 | TetraSens TetraGraph Electrode |
| 07350012440176 | TetraSens with EZconnect |
Trademark Results [TetraSens]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TETRASENS 87323576 5271272 Live/Registered |
Senzime AB (publ.) 2017-02-03 |
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