XI.D-MDT™

Basic Information

• Brand Name: XI.D-MDT™
• Primary DI: 04260451444075
• Version / Model: XI.D-MDT
• Catalog Number: XI.D-MDT
• Company Name: Oscor Inc.
• Labeler DUNS: 101835833
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-11-18
• Public Version: 5
• Public Version Date: 2020-12-03
• Public Version Status: Update
• Public Device Record Key: b45cf17a-6e00-4245-9f43-160e064cbde1
• Distribution End Date: 2020-12-03

Device Description

Disposable Extension Cable

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: 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
IKD	CABLE, ELECTRODE	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47143	Electrical-only medical device connection cable, single-use	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260451444075	GS1
Unit of Use	04260451444082	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070926	000

Device Sizes

Type	Value	Unit	Text
Length	30	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius