XCOIL Encapsulator

GUDID 00855975007055

Vascular guide-catheter, single-use

Primary Device ID	00855975007055
NIH Device Record Key	8b8bd898-8c02-488f-a36d-43a3de82d607
Commercial Distribution Discontinuation	2020-04-30
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	XCOIL Encapsulator
Version Model Number	XE501
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 Issuing Agency	Device ID
GS1	00855975007055 [Primary]

DYB	Introducer, Catheter

Steralize Prior To Use	false
Device Is Sterile	true

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