Home GUDID 00197157058326 ZAVATION INSTRUMENT
Primary DI 00197157058326
Brand ZAVATION INSTRUMENT
Company Zavation LLC
Model 989-1004-CSTM
Device description PEDICLE PROBE, CURVED LENKE-CUSTOM PINNED
Published 2026-06-01
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 NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00197157058326 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 00197157058326 00197157058326 197157058326 0197157058326
GMDN Terms# Term, Definition table Term Definition Stereotactic surgery system probe, reusable A slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 069472800 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 07290115932508 Tower Guide ST PREMIA SPINE LTD NKB 2026-07-23 M719GL201TL0 SIros-X Genesys Orthopedics Systems LLC NKB 2026-07-23 07290115935578 PER Trial 60 PREMIA SPINE LTD NKB 2026-07-22 07290115935691 PER Trial 50 PREMIA SPINE LTD NKB 2026-07-22 00840466901035 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901479 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901486 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901493 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901509 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901516 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901523 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901530 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901547 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901554 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901561 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901578 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901585 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21
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