Home GUDID 08809317177922 SPINAUT-Ix
Primary DI 08809317177922
Brand SPINAUT-Ix
Company IMEDICOM CO., LTD.
Model IX2000
Published 2018-07-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800038026315 Package GS1 10 In Commercial Distribution 08809317177922 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800038026315 08800038026315 8800038026315 08809317177922 08809317177922 8809317177922
GMDN Terms# Term, Definition table Term Definition Subcutaneous tunneller, single-use A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.
Regulatory Flags# DUNS number 690340653 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810166522816 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522823 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522830 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522847 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522854 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522861 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00810166522878 Expanding Innovations EXPANDING INNOVATIONS, INC. LXH 2026-05-27 00889929072424 Matrixx System NEXXT SPINE, LLC LXH 2026-05-27 07640187918809 Straight reamer handle MPS Micro Precision Systems AG LXH 2026-05-27 07613327007114 ES2 SPINAL SYSTEM Stryker Corporation LXH 2019-11-25 07613327007558 XIA 3 Stryker Corporation LXH 2019-11-25 07613327007565 XIA 3 Stryker Corporation LXH 2019-11-25 07613327114881 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327121919 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327126273 AVS Anchor-C Cervical Cage System Stryker Corporation LXH 2019-11-25 07613327142662 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327142679 XIA 4.5 EVOLUTION Stryker Corporation LXH 2019-11-25 07613327177480 OASYS Stryker Corporation LXH 2019-11-25 07613327261752 DIAPASON Stryker Corporation LXH 2019-11-25 07613327261943 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261950 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261967 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261974 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327261998 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262001 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262018 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262025 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262032 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262049 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25 07613327262056 O.I.C. TITANIUM Stryker Corporation LXH 2019-11-25