Home GUDID M97028000201006 Kitsune
Primary DI M97028000201006
Brand Kitsune
Company Medshape, Inc.
Model 2800-02-010
Device description 10mm Staple Drill Guide, reusable, Kitsune
Published 2016-06-01
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 LXI Guide, Drill, Ligament
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXI Guide, Drill, Ligament General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M97028000201006 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, reusable A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 601306413 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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 G453332321055BC010 PEAK MEDICAL Peak Medical Distribution Inc. LXI 2026-05-06 00888867500884 Arthrex® ARTHREX, INC. LXI 2026-03-13 00888867500907 Arthrex® ARTHREX, INC. LXI 2026-03-13 00888867500938 Arthrex® ARTHREX, INC. LXI 2026-03-13 00888867500976 Arthrex® ARTHREX, INC. LXI 2026-03-13 00888867500990 Arthrex® ARTHREX, INC. LXI 2026-03-13 00840124521018 PolyLock Midfoot FUSION ORTHOPEDICS, LLC LXI 2025-06-24 00840124519978 PolyLock Midfoot FUSION ORTHOPEDICS, LLC LXI 2025-05-16 00840124519985 PolyLock Midfoot FUSION ORTHOPEDICS, LLC LXI 2025-05-16 00840124520189 PolyLock Midfoot FUSION ORTHOPEDICS, LLC LXI 2025-05-16 00840124520226 PolyLock Midfoot FUSION ORTHOPEDICS, LLC LXI 2025-05-16 00840124520233 PolyLock Midfoot FUSION ORTHOPEDICS, LLC LXI 2025-05-16 00840124520257 PolyLock Midfoot FUSION ORTHOPEDICS, LLC LXI 2025-05-16 00840124520264 PolyLock Ankle FUSION ORTHOPEDICS, LLC LXI 2025-05-16 00840124520325 PolyLock Ankle FUSION ORTHOPEDICS, LLC LXI 2025-05-16 00840124520332 PolyLock Ankle FUSION ORTHOPEDICS, LLC LXI 2025-05-16 00840124519572 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519589 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519602 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519619 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519664 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519671 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519688 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519695 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519701 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519732 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519787 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519794 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519800 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15 00840124519831 PolyLock FUSION ORTHOPEDICS, LLC LXI 2025-05-15