Tenex Health TX® 557-0017-001

GUDID 00857156006338

Inflation Cuff, 1000cc

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 ID00857156006338
NIH Device Record Keyfe24473a-3c72-4897-8ec4-7602c3ef3aa6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTenex Health TX®
Version Model Number557-0017-001
Catalog Number557-0017-001
Company DUNS038720788
Company NameTENEX HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com
Phone9494547500
Emailregulatory@tenexhealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857156006338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFLInstrument, Ultrasonic Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-23
Device Publish Date2020-07-15

On-Brand Devices [Tenex Health TX®]

00857156006246TX1 Procedure Pack, Shelf Pack, No Supply Kit
00857156006185TX2 Procedure Pack, Shelf Pack, No Supply Kit
00857156006123TX-Bone (TXB) Procedure Pack, Shelf Pack, No Supply Kit
00857156006338Inflation Cuff, 1000cc
00857156006321Inflation Cuff, 500cc
00857156006314Travel Case
00857156006307TX System Console
00857156006291TX Foot Pedal
00857156006277Power Cord, 120V, USA
00857156006260Fuse Set, 5 X 20, 250V, T5A (Set of 2)
00857156006222TX1 Procedure Pack
00857156006208TX1 MicroTip
00857156006161TX2 Procedure Pack
00857156006147TX2 MicroTip
00857156006109TX-Bone (TXB) Procedure Pack
00857156006086TX Supply Kit
00857156006079TX-Bone (TXB) MicroTip
00857156006352Power Cord, 220V, Europe

Trademark Results [Tenex Health TX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TENEX HEALTH TX
TENEX HEALTH TX
86128675 4660881 Live/Registered
Tenex Health, Inc.
2013-11-25

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