Home GUDID 00191083024899 Streamline TL Spinal Fixation System
Primary DI 00191083024899
Brand Streamline TL Spinal Fixation System
Company Rti Surgical, Inc.
Model 10-55-RR-35
Catalog number 10-55-RR-35
Device description ROD, STRAIGHT
Published 2021-06-25
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Single use 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 00846468001315 Previous GS1 0 00191083024899 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 00846468001315 00846468001315 846468001315 0846468001315 00191083024899 00191083024899 191083024899 0191083024899
GMDN Terms# Term, Definition table Term Definition Spinal fixation implant/sterilization container set A collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 117560455 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 00191083047676 RapidEase⢠4564SC 4564SC 2023-11-03 00191083047683 RapidEase⢠4561SC 4561SC 2023-11-03 00191083024554 Streamline TL Spinal Fixation System 10-55-PR-100 10-55-PR-100 2021-06-25 00191083024585 Streamline TL Spinal Fixation System 10-55-PR-115 10-55-PR-115 2021-06-25 00191083024608 Streamline TL Spinal Fixation System 10-55-PR-125 10-55-PR-125 2021-06-25 00191083024615 Streamline TL Spinal Fixation System 10-55-PR-130 10-55-PR-130 2021-06-25 00191083024639 Streamline TL Spinal Fixation System 10-55-PR-140 10-55-PR-140 2021-06-25 00191083024653 Streamline TL Spinal Fixation System 10-55-PR-150 10-55-PR-150 2021-06-25 00191083024707 Streamline TL Spinal Fixation System 10-55-PR-55 10-55-PR-55 2021-06-25 00191083024745 Streamline TL Spinal Fixation System 10-55-PR-75 10-55-PR-75 2021-06-25 00191083024769 Streamline TL Spinal Fixation System 10-55-PR-85 10-55-PR-85 2021-06-25 00191083024776 Streamline TL Spinal Fixation System 10-55-PR-90 10-55-PR-90 2021-06-25 00191083024806 Streamline TL Spinal Fixation System 10-55-RH-150 10-55-RH-150 2021-06-25 00191083024844 Streamline TL Spinal Fixation System 10-55-RHC-200 10-55-RHC-200 2021-06-25 00191083024851 Streamline TL Spinal Fixation System 10-55-RHC-400 10-55-RHC-400 2021-06-25 00191083024868 Streamline TL Spinal Fixation System 10-55-RHC-600 10-55-RHC-600 2021-06-25 00191083024875 Streamline TL Spinal Fixation System 10-55-RR-100 10-55-RR-100 2021-06-25 00191083024882 Streamline TL Spinal Fixation System 10-55-RR-110 10-55-RR-110 2021-06-25 00191083024905 Streamline TL Spinal Fixation System 10-55-RR-40 10-55-RR-40 2021-06-25 00191083024950 Streamline TL Spinal Fixation System 10-55-RR-90 10-55-RR-90 2021-06-25
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