FDA.reportPublic FDA data

Tenex 2nd Generation MicroTip, TXL+, 2.5 WL

Primary DI
00857356008774
Brand
Tenex 2nd Generation MicroTip, TXL+, 2.5 WL
Company
TRICE MEDICAL, INC.
Model
T600-025
Catalog number
T600-025
Published
2025-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K241700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241700000Tenex 2nd Generation SystemTrice Medical, Inc.2024-11-18LFL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857356008811PackageGS13In Commercial Distribution
00857356008774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857356008811008573560088118573560088110857356008811
00857356008774008573560087748573560087740857356008774

GMDN Terms#

Term, Definition table
TermDefinition
Hard/soft-tissue ultrasonic surgical systemAn assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and soft tissue, and possibly bone cement during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009452895
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857356008767Tenex 2nd Generation MicroTip, TXL, 3.0 WLT600-030T600-0302025-03-06
00857356008781Tenex 2nd Generation MicroTip, TXS, 2.0 WLT600-020T600-0202025-03-06
00857356008798Tenex 2nd Generation MicroTip, TXS+, 1.3 WLT600-013T600-0132025-03-06
00857356008842Tenex 2nd Generation ConsoleT600-001T600-0012025-03-06
00857356008859Tenex 2nd Generation Fuse Set3-10-05293-10-05292025-03-06
00861578000386mi-probeT900-011T900-0152018-04-10
10861578000376mi-eye Procedure Kit 5 packT900-0052017-11-10
00857356008026mi-eye 2T200-0102022-12-09
00857356008118mi-eye 2T215-1202022-12-09
00857356008309advansor-tfT500-0102023-03-02
00857356008156SegWAY ECTR-dT400-0232022-12-08
00857356008064mi-tablet 2T200-0202019-04-03
00861578000331mi-eye 2 95mmT200-0952017-06-09
00861578000348Trice Tablet 2 T200-0012017-06-09
00861578000355Trice Tablet 2 T200-001R2017-06-29
00861578000362mi-eye 2 160mmT200-1602017-09-20
00861578000379mi-eye Procedure KitT900-0012017-11-10
00857356008224mi-tablet 3T300-0012022-12-08
00857356008231mi-eye 3T300-0952022-12-09
00857356008248mi-eye 3T315-1202022-12-09

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07613327687149Sonopet iQ+STRYKER CORPORATIONLFL2026-10-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.LFL2026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.LFL2026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.LFL2026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.LFL2026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.LFL2026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.LFL2026-10-05
07613327586565N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
07613327586589N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.LFL2024-03-04
10381780536383CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2023-07-14
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10381780536352CUSA® ClarityINTEGRA LIFESCIENCES (IRELAND) LIMITEDLFL2022-11-15
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07613327548105Sonopet iQSTRYKER CORPORATIONLFL2021-06-14
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