Home GUDID B030SAZ5040060 SPIRA®-A Integrated
Primary DI B030SAZ5040060
Brand SPIRA®-A Integrated
Company CAMBER SPINE TECHNOLOGIES, LLC
Model SAZ-504-006
Device description SPIRA®-A Integrated 30x42mm 15° Implant Caddy
Published 2024-12-16
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FSM Tray, Surgical, Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B030SAZ5040060 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical instrument/implant rack A device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 054205979 Device count 1 Premarket exempt true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B030SPO1530020 VARIANT SPO-153-002 2022-11-25 B030TLP420WR0 Alcantara™ Thoracolumbar Plating TLP-420WR 2025-08-01 B030TLP422WR0 Alcantara™ Thoracolumbar Plating TLP-422WR 2025-08-01 B030TLP424WR0 Alcantara™ Thoracolumbar Plating TLP-424WR 2025-08-01 B030TLP426WR0 Alcantara™ Thoracolumbar Plating TLP-426WR 2025-08-01 B030TLP428WR0 Alcantara™ Thoracolumbar Plating TLP-428WR 2025-08-01 B030TLP430WR0 Alcantara™ Thoracolumbar Plating TLP-430WR 2025-08-01 B030TLP432WR0 Alcantara™ Thoracolumbar Plating TLP-432WR 2025-08-01 B030TLP434WR0 Alcantara™ Thoracolumbar Plating TLP-434WR 2025-08-01 B030TLP436WR0 Alcantara™ Thoracolumbar Plating TLP-436WR 2025-08-01 B030TLP438WR0 Alcantara™ Thoracolumbar Plating TLP-438WR 2025-08-01 B030TLP440WR0 Alcantara™ Thoracolumbar Plating TLP-440WR 2025-08-01 B030TLP1000 Alcantara Thoracolumbar Plating TLP-100 NA 2024-07-18 B030TLP2180 Alcantara Thoracolumbar Plating TLP-218 NA 2024-07-18 B030TLP2200 Alcantara Thoracolumbar Plating TLP-220 NA 2024-07-18 B030TLP2220 Alcantara Thoracolumbar Plating TLP-222 NA 2024-07-18 B030TLP2240 Alcantara Thoracolumbar Plating TLP-224 NA 2024-07-18 B030TLP2260 Alcantara Thoracolumbar Plating TLP-226 NA 2024-07-18 B030TLP2280 Alcantara Thoracolumbar Plating TLP-228 NA 2024-07-18 B030TLP2350 Alcantara Thoracolumbar Plating TLP-235 NA 2024-07-18
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