Home GUDID 00840200405690
LineSider
Primary DI 00840200405690
Brand LineSider
Company Integrity Implants Inc.
Model ASY-00909
Catalog number ASY-00909
Device description MIS-ONLY 5.5-6.0MM POLY AXIAL SCREW DRIVER
Published 2022-03-28
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 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 00840200405690 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 00840200405690 00840200405690 840200405690 0840200405690
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 080300717 Device count 1 Lot or batch true 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 07290115935578 PER Trial 60 PREMIA SPINE LTD NKB 2026-07-22 07290115935691 PER Trial 50 PREMIA SPINE LTD NKB 2026-07-22 00840466901035 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901035 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21