Home GUDID 00840606191739 Overwatch PCF
Primary DI 00840606191739
Brand Overwatch PCF
Company SPINAL ELEMENTS, INC.
Model 33026-000
Device description HANDLE, IN-LINE
Published 2026-07-31
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 00840606191739 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 00840606191739 00840606191739 840606191739 0840606191739
GMDN Terms# Term, Definition table Term Definition Surgical instrument handle, non-torque-limiting A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 610712213 Device count 1 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 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 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 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 00888867544864 Arthrex® ARTHREX, INC. LXH 2026-07-31
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