Zimmertrodes

Basic Information

• Brand Name: Zimmertrodes
• Primary DI: 14053815072932
• Version / Model: 87200173
• Catalog Number: 87200173
• Company Name: Zimmer MedizinSysteme GmbH
• Labeler DUNS: 316111251
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-03-10
• Public Version: 1
• Public Version Date: 2021-03-18
• Public Version Status: New
• Public Device Record Key: 267afb0f-9c7e-407a-8b39-a1b8f89bc889

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35995	Transcutaneous electrical stimulation electrode, single-use	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24053815072939	GS1	Box	8	In Commercial Distribution
Primary	14053815072932	GS1
Package	34053815072936	GS1	Case	5	In Commercial Distribution
Unit of Use	04053815072935	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140340	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Large

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct sunlight, keep in a dry place