SPINAUT-S

Basic Information

• Brand Name: SPINAUT-S
• Primary DI: 08809317177977
• Version / Model: MS1.0-17000
• Company Name: IMEDICOM CO., LTD.
• Labeler DUNS: 690340653
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 22b70006-0937-4769-af6b-7911a34e8deb

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: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRX	Arthroscope	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45090	Flexible fibreoptic epiduroscope	An endoscope with a flexible inserted portion intended for the visual examination and treatment of intractable back and leg pain (e.g., chronic lumbago or sciatica). It is inserted into the body percutaneously through the sacral hiatus during epiduroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to facilitate and/or perform perfusion or wash in the epidural space, dissect epidural adhesions, or deliver medications. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809317177977	GS1

Premarket Submissions

Submission Number	Supplement Number
K151268	000