NEW DEANTRONICS

GUDID 20813527027429

NEW DEANTRONICS TAIWAN LTD.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 20813527027429
• NIH Device Record Key: 946f5348-d680-48ba-85af-3cce699ce489
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEW DEANTRONICS
• Version Model Number: E0560SI
• Company DUNS: 657365227
• Company Name: NEW DEANTRONICS TAIWAN LTD.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20813527027429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982130

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-30

On-Brand Devices [NEW DEANTRONICS]

• 20813527027443: E0560NCS
• 20813527027436: E0560LI
• 20813527027429: E0560SI