XI.R™ XI.R

GUDID 00836559006312

Reusable Extension Cable

Oscor Inc.

Electrical-only medical device connection cable, single-use

• Primary Device ID: 00836559006312
• NIH Device Record Key: 4590b658-1976-4058-ae0b-ee975f0e04d9
• Commercial Distribution Discontinuation: 2018-05-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: XI.R™
• Version Model Number: XI.R
• Catalog Number: XI.R
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(727)937-2511
• Email: sales@oscor.com

Device Dimensions

• Length: 35 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836559006312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070926

FDA Product Code

• IKD: CABLE, ELECTRODE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-26

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