Home GUDID 00840194418256 Response 5.5/6.0
Primary DI 00840194418256
Brand Response 5.5/6.0
Company ORTHOPEDIATRICS CORP.
Model 01-1300-8335
Catalog number 01-1300-8335
Device description Response 5.5/6.0 Pedicle Screw Driver, ZH Drive
Published 2025-05-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 00840194418256 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 00840194418256 00840194418256 840194418256 0840194418256
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 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 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 00840536822741 Response 5.5/6.0 01-1300-6535 01-1300-6535 2026-05-30 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
Other Devices Sharing Product Codes# 
xxx.com