Home GUDID 00840916150174 SAVANNAH
Primary DI 00840916150174
Brand SAVANNAH
Company SPINAL ELEMENTS
Model 9004
Device description CANNULATED TAP
Published 2020-04-16
Public version status Update
Distribution status Not 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 00840916150174 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 00840916150174 00840916150174 840916150174 0840916150174
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 004022104 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 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 00840606186414 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26