Home GUDID 00840019971195 Reform Ti Modular
Primary DI 00840019971195
Brand Reform Ti Modular
Company PRECISION SPINE, INC.
Model 39-SF-7540
Catalog number 39-SF-7540
Device description Modular Fenestrated Bone-Screw - 7.5 mm x 40 mm
Published 2026-01-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NKB Thoracolumbosacral Pedicle Screw System PML Bone Cement, Posterior Screw Augmentation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2 PML Bone Cement, Posterior Screw Augmentation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840019971195 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 00840019971195 00840019971195 840019971195 0840019971195
GMDN Terms# Term, Definition table Term Definition Spinal fixation implant/sterilization container set A collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 079398589 Device count 1 DM exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840019904650 Slimplicity Anterior Cervical Plate System ACP118 ACP118 2019-04-11 00840019904667 Slimplicity Anterior Cervical Plate System ACP120 ACP120 2019-04-11 00840019904674 Slimplicity Anterior Cervical Plate System ACP122 ACP122 2019-04-11 00840019904681 Slimplicity Anterior Cervical Plate System ACP124 ACP124 2019-04-11 00840019904698 Slimplicity Anterior Cervical Plate System ACP126 ACP126 2019-04-11 00840019904704 Slimplicity Anterior Cervical Plate System ACP128 ACP128 2019-04-11 00815362021446 Slimplicity Anterior Cervical Plate System 08-9020 08-9020 2019-04-01 00815362021453 Slimplicity Anterior Cervical Plate System 08-9021 08-9021 2019-04-01 00815362021460 Slimplicity Anterior Cervical Plate System 08-9024 08-9024 2019-04-01 00815362021477 Slimplicity Anterior Cervical Plate System 08-9025 08-9025 2019-04-01 00815362021484 Slimplicity Anterior Cervical Plate System 08-9026 08-9026 2019-04-01 00815362021729 Slimplicity Anterior Cervical Plate System 50-0018 50-0018 2019-04-01 00815362021088 Slimplicity Anterior Cervical Plate System 08-0112 08-0112 2019-03-29 00815362021118 Slimplicity Anterior Cervical Plate System 08-0118 08-0118 2019-03-29 00815362021125 Slimplicity Anterior Cervical Plate System 08-0120 08-0120 2019-03-29 00815362021132 Slimplicity Anterior Cervical Plate System 08-0122 08-0122 2019-03-29 00815362021149 Slimplicity Anterior Cervical Plate System 08-0124 08-0124 2019-03-29 00815362021156 Slimplicity Anterior Cervical Plate System 08-0126 08-0126 2019-03-29 00815362021163 Slimplicity Anterior Cervical Plate System 08-0128 08-0128 2019-03-29 00815362021170 Slimplicity Anterior Cervical Plate System 08-0226 08-0226 2019-03-29
Other Devices Sharing Product Codes#