XCOIL Encapsulator

GUDID 00855975007048

XCOIL Encapsulator - 11mm x 80cm

Nexgen Medical Systems, Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00855975007048
• NIH Device Record Key: 1ccda937-a7ed-4a97-b8a4-9b02d078e070
• Commercial Distribution Discontinuation: 2020-04-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: XCOIL Encapsulator
• Version Model Number: XE400
• 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: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter
• Length: 80 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855975007048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102925

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-05-01
• Device Publish Date: 2017-05-31

On-Brand Devices [XCOIL Encapsulator]

• 00855975007055: Encapsulator 16mm x 70cm
• 00855975007048: XCOIL Encapsulator - 11mm x 80cm