Inion S-2 instrument

Basic Information

• Brand Name: Inion S-2 instrument
• Primary DI: M224ACC984210
• Version / Model: 1
• Catalog Number: ACC-9842
• Company Name: Inion Oy
• Labeler DUNS: 367994657
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 10
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: f5e2f092-18d4-4e15-b718-856953e174b6

Device Description

Sterilization tray for instruments

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJB	Resorbable spinal intervertebral body fixation orthosis - plate	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12143	Instrument tray, reusable	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M224ACC984210	HIBCC
Secondary	06438408005091	GS1

Premarket Submissions

Submission Number	Supplement Number
K071810	000