XCOIL Encapsulator

GUDID 00855975007055

Encapsulator 16mm x 70cm

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 ID00855975007055
NIH Device Record Key8b8bd898-8c02-488f-a36d-43a3de82d607
Commercial Distribution Discontinuation2020-04-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameXCOIL Encapsulator
Version Model NumberXE501
Company DUNS018652637
Company NameNexgen Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter
Length70 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100855975007055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-01
Device Publish Date2018-10-16

On-Brand Devices [XCOIL Encapsulator]

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

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