XCOIL Retractor

GUDID 00855975007062

Retractor 18mm x 125cm

Nexgen Medical Systems, Inc.

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• Primary Device ID: 00855975007062
• NIH Device Record Key: fcee7147-2be7-4960-9c31-cea11459007b
• Commercial Distribution Discontinuation: 2020-04-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: XCOIL Retractor
• Version Model Number: XR200
• Company DUNS: 018652637
• Company Name: Nexgen Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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

Device Dimensions

• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter
• Length: 125 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855975007062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110315

FDA Product Code

• DXE: Catheter, Embolectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-01
• Device Publish Date: 2018-10-16

On-Brand Devices [XCOIL Retractor]

• 00855975007062: Retractor 18mm x 125cm
• 00855975007031: XCOIL Retractor - 12mm x 125cm (Long Eyelet)
• 00855975007024: XCOIL Retractor - 12mm x 125cm (Short Eyelet)