Home GUDID 05397283000151 Pro-X1
Primary DI 05397283000151
Brand Pro-X1
Company X-BOLT ORTHOPEDICS INC.
Model XNI-017
Device description Removal Rod
Published 2024-08-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HSB Rod, Fixation, Intramedullary And Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSB Rod, Fixation, Intramedullary And Accessories Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05397283000151 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05397283000151 05397283000151 5397283000151
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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 119116284 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00887868150876 Affixus® Zimmer, Inc. HSB 2026-03-20 00887868150333 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150340 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150357 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150364 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150371 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150388 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150395 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150401 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150555 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150562 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150579 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150586 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150593 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150609 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150616 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150883 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150890 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150906 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150913 Affixus® Zimmer, Inc. HSB 2026-03-19 00887868150920 Affixus® Zimmer, Inc. HSB 2026-03-19 00889024700253 Affixus® Zimmer, Inc. HSB 2026-03-19 00889024700260 Affixus® Zimmer, Inc. HSB 2026-03-19 00889024700277 Affixus® Zimmer, Inc. HSB 2026-03-19 00889024700284 Affixus® Zimmer, Inc. HSB 2026-03-19 00889024700291 Affixus® Zimmer, Inc. HSB 2026-03-19 00888867463363 Arthrex® ARTHREX, INC. HSB 2026-03-16 00888867529069 Arthrex® ARTHREX, INC. HSB 2026-03-16 00888867529076 Arthrex® ARTHREX, INC. HSB 2026-03-16 00888867529137 Arthrex® ARTHREX, INC. HSB 2026-03-16