Home GUDID 07540194010308 GAP ENDO-EXO MEDULLARY SYSTEM
Primary DI 07540194010308
Brand GAP ENDO-EXO MEDULLARY SYSTEM
Company Orthopediatrics Canada ULC
Model GAP-THA100
Catalog number GAP-THA100
Device description GAP AXIAL HANDLE
Published 2020-08-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx 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 07540194010308 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07540194010308 07540194010308 7540194010308
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant/trial-implant/sizer holder, reusable A hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 keep at room temperature
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 243298854 Device count 1 DM exempt true Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07540194018168 Dr.Paleys Osteotomy System DRPO-706 DRPO-706 2026-03-11 07540194013163 The Locking Pediatric Osteotomy Plate (LolliPOP) System POP-IMP100-C POP-IMP100-C 2021-11-30 07540194008916 The Locking Pediatric Osteotomy Plate (LolliPOP) System POP-CAP100 POP-CAP100 2020-08-12 07540194009067 The Locking Pediatric Osteotomy Plate (LolliPOP) System POP-IMP100 POP-IMP100 2020-08-12 07540194002181 GAP ENDO-EXO MEDULLARY SYSTEM GAP-CP015 GAP-CP015 2016-10-20 07540194002198 GAP ENDO-EXO MEDULLARY SYSTEM GAP-CP050 GAP-CP050 2016-10-20 07540194002204 GAP ENDO-EXO MEDULLARY SYSTEM GAP-CP100 GAP-CP100 2016-10-20 07540194002396 FREE GLIDING SCFE SCREW SYSTEM SCF-MC-065 SCF-MC-065 2016-10-20 07540194002570 FREE GLIDING SCFE SCREW SYSTEM SCF-MC-073 SCF-MC-073 2016-10-20 07540194004215 SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-CAP-315 SLM-CAP-315 2016-10-20 07540194004222 SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-CAP-350 SLM-CAP-350 2016-10-20 07540194004239 SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-CAP-415 SLM-CAP-415 2016-10-20 07540194004246 SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLM-CAP-450 SLM-CAP-450 2016-10-20 07540194009982 GAP ENDO-EXO MEDULLARY SYSTEM GAP-KDG360-PKG2 GAP-KDG360-PKG2 2020-08-12 07540194009999 GAP ENDO-EXO MEDULLARY SYSTEM GAP-KDG360-PKG6 GAP-KDG360-PKG6 2020-08-12 07540194016737 GAP ENDO-EXO MEDULLARY SYSTEM GAP-SDG200 GAP-SDG200 2024-06-13 07540194009975 GAP ENDO-EXO MEDULLARY SYSTEM GAP-KDG360 GAP-KDG360 2020-08-12 07540194017956 GIRO GROWTH MODULATION SYSTEM GRO-CYF250-35 GRO-CYF250-35 2025-03-31 07540194015907 HINGE PEDIATRIC PLATING SYSTEM HP-CYF250 HP-CYF250 2024-09-11 07540194015921 GIRO GROWTH MODULATION SYSTEM GRO-CYF150-45 GRO-CYF150-45 2024-09-11
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