XCOIL Retractor

GUDID 00855975007024

XCOIL Retractor - 12mm x 125cm (Short Eyelet)

Nexgen Medical Systems, Inc.

Thrombectomy wire-net
Primary Device ID00855975007024
NIH Device Record Key67db1b6b-7374-42dd-afb6-a8a2b96f9ded
Commercial Distribution Discontinuation2020-04-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameXCOIL Retractor
Version Model NumberXR100-2
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

Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter
Length125 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100855975007024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-05-01
Device Publish Date2017-05-31

On-Brand Devices [XCOIL Retractor]

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

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