Tenex Health TX® 554-3003-001

GUDID 00857156006109

TX-Bone (TXB) Procedure Pack

TENEX HEALTH, INC.

Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system Ultrasonic suction system

• Primary Device ID: 00857156006109
• NIH Device Record Key: d6d0eb01-87c8-4341-9db4-c87f494a4501
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenex Health TX®
• Version Model Number: 554-3003-001
• Catalog Number: 554-3003-001
• 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: true
• 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

• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857156006093 [Primary]
GS1	00857156006109 [Package]; Contains: 00857156006093; Package: Box [1 Units]; In Commercial Distribution
GS1	00857156006116 [Package]; Contains: 00857156006093; Package: Box [3 Units]; In Commercial Distribution

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: 2020-07-23
• Device Publish Date: 2020-07-15

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