Tenex Health TX® 430-4024-001
GUDID 00857156006352
Power Cord, 220V, Europe
TENEX HEALTH, INC.
Ultrasonic suction system| Primary Device ID | 00857156006352 |
| NIH Device Record Key | 20a7d42d-47d5-4855-b27b-253c8a981726 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tenex Health TX® |
| Version Model Number | 430-4024-001 |
| Catalog Number | 430-4024-001 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857156006352 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123640
FDA Product Code
| LFL | Instrument, Ultrasonic Surgical |
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 | 2021-05-25 |
| Device Publish Date | 2021-05-17 |
On-Brand Devices [Tenex Health TX®]
| 00857156006246 | TX1 Procedure Pack, Shelf Pack, No Supply Kit |
| 00857156006185 | TX2 Procedure Pack, Shelf Pack, No Supply Kit |
| 00857156006123 | TX-Bone (TXB) Procedure Pack, Shelf Pack, No Supply Kit |
| 00857156006338 | Inflation Cuff, 1000cc |
| 00857156006321 | Inflation Cuff, 500cc |
| 00857156006314 | Travel Case |
| 00857156006307 | TX System Console |
| 00857156006291 | TX Foot Pedal |
| 00857156006277 | Power Cord, 120V, USA |
| 00857156006260 | Fuse Set, 5 X 20, 250V, T5A (Set of 2) |
| 00857156006222 | TX1 Procedure Pack |
| 00857156006208 | TX1 MicroTip |
| 00857156006161 | TX2 Procedure Pack |
| 00857156006147 | TX2 MicroTip |
| 00857156006109 | TX-Bone (TXB) Procedure Pack |
| 00857156006086 | TX Supply Kit |
| 00857156006079 | TX-Bone (TXB) MicroTip |
| 00857156006352 | Power Cord, 220V, Europe |
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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