Tenex Health TX 554-4003-002
GUDID 00857156006406
TX-DFU Procedure Pack, Shelf Pack
TENEX HEALTH, INC.
Ultrasonic suction system| Primary Device ID | 00857156006406 |
| NIH Device Record Key | d7a176fb-c88d-4f1f-94f6-b11c0fa0d615 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tenex Health TX |
| Version Model Number | 554-4003-002 |
| Catalog Number | 554-4003-002 |
| Company DUNS | 038720788 |
| Company Name | TENEX HEALTH, INC. |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857156006390 [Package] Contains: 20857156006073 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 00857156006406 [Package] Contains: 20857156006073 Package: Box [3 Units] In Commercial Distribution |
| GS1 | 20857156006073 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181367
FDA Product Code
| LFL | Instrument, Ultrasonic Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-03 |
| Device Publish Date | 2022-02-23 |
Devices Manufactured by TENEX HEALTH, INC.
| 00857156006406 - Tenex Health TX | 2022-03-03TX-DFU Procedure Pack, Shelf Pack |
| 00857156006406 - Tenex Health TX | 2022-03-03 TX-DFU Procedure Pack, Shelf Pack |
| 00857156006352 - Tenex Health TX® | 2021-05-25 Power Cord, 220V, Europe |
| 00857156006079 - Tenex Health TX® | 2020-07-23 TX-Bone (TXB) MicroTip |
| 00857156006086 - Tenex Health TX® | 2020-07-23 TX Supply Kit |
| 00857156006109 - Tenex Health TX® | 2020-07-23 TX-Bone (TXB) Procedure Pack |
| 00857156006147 - Tenex Health TX® | 2020-07-23 TX2 MicroTip |
| 00857156006161 - Tenex Health TX® | 2020-07-23 TX2 Procedure Pack |
| 00857156006208 - Tenex Health TX® | 2020-07-23 TX1 MicroTip |
Trademark Results [Tenex Health TX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENEX HEALTH TX 86128675 4660881 Live/Registered |
Tenex Health, Inc. 2013-11-25 |
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