TOF-STICKER1

Basic Information

• Brand Name: TOF-STICKER1
• Primary DI: 03665023000153
• Version / Model: TOF-STICKER1
• Catalog Number: TOF-STICKER1
• Company Name: IDMED
• Labeler DUNS: 260233256
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 96
• Record Status: Published
• Publish Date: 2018-10-04
• Public Version: 2
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: a05e7258-2f3b-4447-912b-5d0dae649783

Device Description

Double-sided stickers for eyebrow sensor (96 units)

Device Characteristics

• Single Use: Yes
• 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: MR Unsafe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	868.2775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59693	Neuromuscular transmission lead set	A device(s) intended exclusively to conduct electrical neuromuscular transmission (NMT) signals to/from an array of neuromuscular electrodes attached to the surface of the skin of the hand and forearm, or the foot. The signals are subsequently conducted via a cable to a patient monitoring module to assess the degree of neuromuscular block in a patient. The patient-contact electrodes are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03665023000153	GS1
Unit of Use	03665023000412	GS1

Premarket Submissions

Submission Number	Supplement Number
K172690	000