Home GUDID 00191083033266 Cross-Fuse® II PEEK IBF System
Primary DI 00191083033266
Brand Cross-Fuse® II PEEK IBF System
Company Rti Surgical, Inc.
Model 38-INSERTER2-HL
Catalog number 38-INSERTER2-HL
Device description INSERTER
Published 2022-03-02
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 LXH Orthopedic manual surgical instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00191083033266 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 00191083033266 00191083033266 191083033266 0191083033266
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant inserter/extractor, reusable A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
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# 
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