Home GUDID 00840536822741 Response 5.5/6.0
Primary DI 00840536822741
Brand Response 5.5/6.0
Company ORTHOPEDIATRICS CORP.
Model 01-1300-6535
Catalog number 01-1300-6535
Device description Response 5.5/6.0 Narrow Pedicle Screw Driver
Published 2026-05-30
Public version status New
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 KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL NKB Thoracolumbosacral pedicle screw system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840194497503 Previous GS1 0 00840536822741 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840194497503 00840194497503 840194497503 0840194497503 00840536822741 00840536822741 840536822741 0840536822741
GMDN Terms# Term, Definition table Term Definition Surgical screwdriver, reusable A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 796416191 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 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840536800039 3P Hip System 01-3002-1013 01-3002-1013 2026-06-09 00840536800046 3P Hip System 01-3002-2013 01-3002-2013 2026-06-09 00840536800053 3P Hip System 01-3002-3013 01-3002-3013 2026-06-09 00840536800060 3P Hip System 01-3035-0050 01-3035-0050 2026-06-09 00840536822758 Response 5.5/6.0 01-1300-6536 01-1300-6536 2026-05-30 00840536822543 Prone Perfect 03-1300-8801 03-1300-8801 2026-05-22 00840536822550 Prone Perfect 03-1300-8802 03-1300-8802 2026-05-22 00840536822567 Prone Perfect 03-1300-8803 03-1300-8803 2026-05-22 00840536822574 Prone Perfect 03-1300-8804 03-1300-8804 2026-05-22 00840536822581 Prone Perfect 03-1300-8805 03-1300-8805 2026-05-22 00840536822598 Prone Perfect 03-1300-8806 03-1300-8806 2026-05-22 00840536822604 Prone Perfect 03-1300-8807 03-1300-8807 2026-05-22 00840536822611 Prone Perfect 03-1300-8808 03-1300-8808 2026-05-22 00840536822628 Prone Perfect 03-1300-8809 03-1300-8809 2026-05-22 00840536822635 Prone Perfect 03-1300-8810 03-1300-8810 2026-05-22 00840536822642 Prone Perfect 03-1300-8811 03-1300-8811 2026-05-22 00841132199244 OrthoPediatrics Locking Cannulated Blade Plate System 00-1200-6000-S 00-1200-6000-S 2026-05-13 00841132199251 OrthoPediatrics Locking Cannulated Blade Plate System 00-1200-6001-S 00-1200-6001-S 2026-05-13 00841132199268 OrthoPediatrics Locking Cannulated Blade Plate System 00-1200-6002-S 00-1200-6002-S 2026-05-13 00841132199275 OrthoPediatrics Locking Cannulated Blade Plate System 00-1200-6003-S 00-1200-6003-S 2026-05-13
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