Home GUDID 00850041805863 X-PAC
Primary DI 00850041805863
Brand X-PAC
Company EXPANDING INNOVATIONS, INC.
Model EI2608
Device description X-PAC Wedge Rasp Dilator
Published 2026-07-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false
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 00850041805863 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 00850041805863 00850041805863 850041805863 0850041805863
GMDN Terms# Term, Definition table Term Definition Orthopaedic surgical distractor, external A hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be stabilized against a fixation point adjacent to the target joint (e.g., between the knee and the thigh for knee distraction, or between the joint and a patient positioner attached to the operating table). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081309444 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true 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 M9432002220000 Minuteman Spinal Simplicity, LLC LXH 2026-09-04 07613327697209 PANGEA Stryker GmbH LXH 2026-08-27 00840606185950 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185967 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185974 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185981 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185998 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186001 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186018 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186025 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186032 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186049 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186056 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186063 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186070 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186087 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186094 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186100 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186117 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186124 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186131 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186148 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186155 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186162 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186179 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186186 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186193 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186209 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186247 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186254 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26