Home GUDID 08406061019494 Karma
Primary DI 08406061019494
Brand Karma
Company SPINAL ELEMENTS, INC.
Model 75226-000
Device description Karma Retriever
Published 2019-03-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name OWI Bone Fixation Cerclage, Sublaminar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OWI Bone Fixation Cerclage, Sublaminar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08406061019494 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08406061019494 08406061019494 8406061019494
GMDN Terms# Term, Definition table Term Definition Orthopaedic cerclage applier A hand-held manual surgical instrument designed to position and secure or bind an orthopaedic cerclage loop, clamp, or wire. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 610712213 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190376696140 Invictus ALPHATEC SPINE, INC. OWI 2026-04-09 00190376696157 Invictus ALPHATEC SPINE, INC. OWI 2026-04-09 00190376721699 Invictus ALPHATEC SPINE, INC. OWI 2026-04-09 00190376721705 Invictus ALPHATEC SPINE, INC. OWI 2026-04-09 00190376721712 Invictus ALPHATEC SPINE, INC. OWI 2026-04-09 00763000881696 TRANSLACE™ Spinal Tethering System MEDTRONIC SOFAMOR DANEK, INC. OWI 2026-02-05 00763000881702 TRANSLACE™ Spinal Tethering System MEDTRONIC SOFAMOR DANEK, INC. OWI 2026-02-05 00840085278518 ALTA Astura Medical OWI 2026-02-03 00840085277603 ALTA Astura Medical OWI 2026-02-02 00840085278051 ALTA Astura Medical OWI 2026-02-02 00840085278068 ALTA Astura Medical OWI 2026-02-02 10888857581852 NILE™ Alternative Fixation System VB Spine LLC OWI 2025-03-21 00887517721518 VersaTie Nuvasive, Inc. OWI 2024-11-27 00763000675035 TRANSLACE™ Spinal Tethering System MEDTRONIC SOFAMOR DANEK, INC. OWI 2024-11-04 00193982506216 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506223 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506230 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506247 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506254 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506261 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506278 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506285 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506292 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506445 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506452 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506469 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506476 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506490 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506513 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22 00193982506520 HILINE GLOBUS MEDICAL, INC. OWI 2024-07-22