Home GUDID 00191083028491 MaxFuse PEEK VBR SYSTEM
Primary DI 00191083028491
Brand MaxFuse PEEK VBR SYSTEM
Company Rti Surgical, Inc.
Model 724-844
Catalog number 724-844
Device description MAXFUSE,14.5x17x1618 REPLICA TRL SPACER
Published 2020-09-25
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name HWT TEMPLATE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWT Template Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00191083015606 Primary GS1 0 00191083028491 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 00191083015606 00191083015606 191083015606 0191083015606 00191083028491 00191083028491 191083028491 0191083028491
GMDN Terms# Term, Definition table Term Definition Surgical implant template, reusable A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 117560455 Device count 1 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 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 00191083024899 Streamline TL Spinal Fixation System 10-55-RR-35 10-55-RR-35 2021-06-25 00191083024905 Streamline TL Spinal Fixation System 10-55-RR-40 10-55-RR-40 2021-06-25
Other Devices Sharing Product Codes# 
exalta.com
rtix.com