FDA.reportPublic FDA data

Tenex Health TX®

Primary DI
00857156006109
Brand
Tenex Health TX®
Company
TENEX HEALTH, INC.
Model
554-3003-001
Catalog number
554-3003-001
Device description
TX-Bone (TXB) Procedure Pack
Published
2020-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFLInstrument, Ultrasonic Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFLInstrument, Ultrasonic SurgicalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181367000Tenex Health TX System with the TXP MicroTipTenex Health, Inc.2018-08-28LFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857156006109PackageGS11In Commercial Distribution
00857156006116PackageGS13In Commercial Distribution
00857156006093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857156006109008571560061098571560061090857156006109
00857156006116008571560061168571560061160857156006116
00857156006093008571560060938571560060930857156006093

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic suction systemAn assembly of mains electricity (AC-powered) devices designed to use mechanical ultrasonic vibration and a combination of irrigation and suction to fragment and remove soft tissue and growths of high water content from various parts of the body. Ultrasonic suction units are used during neurosurgery, general surgery, and gynaecological and orthopaedic procedures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9494547500regulatory@tenexhealth.com

Regulatory Flags#

DUNS number
038720788
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20857156006073Tenex Health TX554-4003-002554-4003-0022022-02-23
00857156006406Tenex Health TX554-4003-002554-4003-0022022-02-23
00857156006352Tenex Health TX®430-4024-001430-4024-0012021-05-17
10857156006076Tenex Health TX®554-3003-002554-3003-0022020-07-15
10857156006144Tenex Health TX®554-2003-002554-2003-0022020-07-15
10857156006205Tenex Health TX®554-1003-002554-1003-0022020-07-15
00857156006093Tenex Health TX®554-3003-001554-3003-0012020-07-15
00857156006154Tenex Health TX®554-2003-001554-2003-0012020-07-15
00857156006215Tenex Health TX®554-1003-001554-1003-0012020-07-15
00857156006079Tenex Health TX®557-1002-0012020-07-15
00857156006086Tenex Health TX®554-1001-0012020-07-15
00857156006147Tenex Health TX®554-2002-0012020-07-15
00857156006161Tenex Health TX®554-2003-001554-2003-0012020-07-15
00857156006208Tenex Health TX®554-1002-0012020-07-15
00857156006222Tenex Health TX®554-1003-001554-1003-0012020-07-15
00857156006260Tenex Health TX®430-2215-002430-2215-0022020-07-15
00857156006277Tenex Health TX®430-4023-001430-4023-0012020-07-15
00857156006291Tenex Health TX®554-0001-001554-0001-0012020-07-15
00857156006307Tenex Health TX®554-0000-000554-0000-0002020-07-15
00857156006314Tenex Health TX®551-7002-001551-7002-0012020-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327586565N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
07613327586589N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
10381780536383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-07-14
10381780533870CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-06-21
10381780533894CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-06-21
07613327576627Sonopet iQSTRYKER CORPORATIONLFL2023-03-24
10381780536369CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
10381780536352CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
10381780533863CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-09-06
07613327548105Sonopet iQSTRYKER CORPORATIONLFL2021-06-14
10884521807884SonicisionCovidien LPLFL2020-06-29
07613327298635Sonopet iQSTRYKER CORPORATIONLFL2019-05-10
10381780466215CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-05-07
10381780466383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-05-07
07613327422382Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422399Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422405Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422412Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422429Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422436Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422443Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422450Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422467Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422474Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422481Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422498Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422504Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422511Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
07613327422528Sonopet iQSTRYKER CORPORATIONLFL2019-05-02
10381780126416CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2019-02-08