Home GUDID 00850075111091 Native
Primary DI 00850075111091
Brand Native
Company INS ORTHO INC.
Model 416.000
Catalog number 416.000
Device description Spear Passer Needle 5-Pack
Published 2026-02-26
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use 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 00850075111107 Primary GS1 0 00850075111091 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850075111107 00850075111107 850075111107 0850075111107 00850075111091 00850075111091 850075111091 0850075111091
GMDN Terms# Term, Definition table Term Definition Suturing unit, single-use A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.
Regulatory Flags# DUNS number 145088199 Device count 5 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00199150083473 Medtronic Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. LXH 2026-08-03 B382SD480033220 Surgical Direct Surgical Direct, Inc. LXH 2026-08-03 B382SD480090 Surgical Direct Surgical Direct, Inc. LXH 2026-08-03 B382SD4834330 Surgical Direct Surgical Direct, Inc. LXH 2026-08-03 B382SD493760 Surgical Direct Surgical Direct, Inc. LXH 2026-08-03 00190776407391 Millennium Avalign Technologies, Inc. LXH 2026-07-31 00840606191579 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191630 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191647 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191678 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191685 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191692 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191708 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191722 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191739 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191777 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191920 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191937 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191968 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00840606191999 Overwatch PCF SPINAL ELEMENTS, INC. LXH 2026-07-31 00888867532236 Arthrex® ARTHREX, INC. LXH 2026-07-31 00888867532243 Arthrex® ARTHREX, INC. LXH 2026-07-31 00888867532250 Arthrex® ARTHREX, INC. LXH 2026-07-31 00888867532267 Arthrex® ARTHREX, INC. LXH 2026-07-31 00888867532274 Arthrex® ARTHREX, INC. LXH 2026-07-31 00888867544819 Arthrex® ARTHREX, INC. LXH 2026-07-31 00888867544826 Arthrex® ARTHREX, INC. LXH 2026-07-31 00888867544833 Arthrex® ARTHREX, INC. LXH 2026-07-31 00888867544840 Arthrex® ARTHREX, INC. LXH 2026-07-31 00888867544857 Arthrex® ARTHREX, INC. LXH 2026-07-31
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