FDA.reportPublic FDA data

Xenix Medical Universal Handle

Primary DI
00840493416601
Brand
Xenix Medical Universal Handle
Company
XENIX MEDICAL LLC
Model
UN1-H0-241004
Catalog number
UN1-H0-241004
Device description
T-Handle, Large Hudson, Fixed, Black
Published
2025-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840493416601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493416601008404934166018404934166010840493416601

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080386764
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493422398RIVA Pedicle Screw SystemFG1-16-200030FG1-16-2000302026-06-03
00840493422404RIVA Pedicle Screw SystemFG1-16-200035FG1-16-2000352026-06-03
00840493422411RIVA Pedicle Screw SystemFG1-16-200040FG1-16-2000402026-06-03
00840493422428RIVA Pedicle Screw SystemFG1-16-200045FG1-16-2000452026-06-03
00840493422435RIVA Pedicle Screw SystemFG1-16-200050FG1-16-2000502026-06-03
00840493422442RIVA Pedicle Screw SystemFG1-16-200055FG1-16-2000552026-06-03
00840493422459RIVA Pedicle Screw SystemFG1-16-200060FG1-16-2000602026-06-03
00840493422466RIVA Pedicle Screw SystemFG1-16-200065FG1-16-2000652026-06-03
00840493422473RIVA Pedicle Screw SystemFG1-16-200070FG1-16-2000702026-06-03
00840493422480RIVA Pedicle Screw SystemFG1-16-200075FG1-16-2000752026-06-03
00840493422497RIVA Pedicle Screw SystemFG1-16-200080FG1-16-2000802026-06-03
00840493422503RIVA Pedicle Screw SystemFG1-16-200085FG1-16-2000852026-06-03
00840493422510RIVA Pedicle Screw SystemFG1-16-200090FG1-16-2000902026-06-03
00840493422527RIVA Pedicle Screw SystemFG1-16-200095FG1-16-2000952026-06-03
00840493422534RIVA Pedicle Screw SystemFG1-16-200100FG1-16-2001002026-06-03
00840493422541RIVA Pedicle Screw SystemFG1-16-200110FG1-16-2001102026-06-03
00840493422558RIVA Pedicle Screw SystemFG1-16-200120FG1-16-2001202026-06-03
00840493422565RIVA Pedicle Screw SystemFG1-16-200130FG1-16-2001302026-06-03
00840493422572RIVA Pedicle Screw SystemFG1-16-200140FG1-16-2001402026-06-03
00840493422589RIVA Pedicle Screw SystemFG1-16-200150FG1-16-2001502026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
08698940971454SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00199150077366Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027246InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00843511128777Omnia Medical TiBrid™-A/SAOMNIA MEDICAL, LLCLXH2026-06-01
00857915007712ObturatorA.M. SURGICAL, INC.LXH2026-06-01
00857915007729CannulaA.M. SURGICAL, INC.LXH2026-06-01
00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
07899258648729Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mmShukla MedicalLXH2026-06-01
10884450587727PowerCURVE®Merit Medical Systems, Inc.LXH2026-05-30
00818720013381SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-05-29
00843575124395Juveno™ Femoral Hip SystemB-ONE ORTHO, CORP.LXH2026-05-29
07630345728883Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542726170Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753787Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753794Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788833Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788840Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788857Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788864Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788871Surgical Manual InstrumentMedacta International SALXH2026-05-29