SPINAUT-E

Basic Information

• Brand Name: SPINAUT-E
• Primary DI: 08809317177359
• Version / Model: S2000
• 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: da323aa2-8b3f-46c5-8706-4b8846db0e59

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47079	Spinal infusion/drainage catheter	A sterile flexible tube intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column for infusion of materials (typically anaesthetic or analgesic substances during surgery, labour, or delivery), and/or drainage of cerebrospinal fluid (CSF) and/or other fluids. Devices intended to assist catheter insertion (e.g., Tuohy needle, suture) may be included. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809317177359	GS1

Premarket Submissions

Submission Number	Supplement Number
K150789	000