Home GUDID 07540194010490
Dr.Paleys Osteotomy System
Primary DI 07540194010490
Brand Dr.Paleys Osteotomy System
Company Orthopediatrics Canada ULC
Model DRPAP-902
Catalog number DRPAP-902
Device description Dr PALEY AUXILIARY PIN
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 07540194010490 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07540194010490 07540194010490 7540194010490
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone pin, non-bioabsorbable A small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use 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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