DuraFuse Dural Clip Applier

GUDID 00860007130410

The NeuraMedica Applier is a separately-supplied reusable instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips.

Neuramedica Inc.

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Primary Device ID00860007130410
NIH Device Record Key28da81a5-a83d-4e61-99a9-4122446e4cfe
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraFuse Dural Clip Applier
Version Model NumberAP-100
Company DUNS079885939
Company NameNeuramedica Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com
Phone503-914-0723
Emailrachel@NeuraMedica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860007130410 [Primary]

FDA Product Code

FZPClip, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-23
Device Publish Date2023-05-15

Devices Manufactured by Neuramedica Inc.

00860007130410 - DuraFuse Dural Clip Applier2023-05-23The NeuraMedica Applier is a separately-supplied reusable instrument that aids in the installation of the NeuraMedica Durafuse Dural Clips.
00860007130410 - DuraFuse Dural Clip Applier2023-05-23 The NeuraMedica Applier is a separately-supplied reusable instrument that aids in the installation of the NeuraMedica Durafuse D
00860007130427 - DuraFuse Dural Clip Instrument Tray 2023-05-23 The NeuraMedica Instrument Tray is a separately-supplied reusable surgical tray that holds the instrument that aids in the insta
00860007130434 - DuraFuse Dural Clip Instrument Tray W/ Appliers2023-05-23 The NeuraMedica Instrument Tray is a separately-supplied reusable surgical tray that holds the instrument that aids in the insta
00860007130403 - DuraFuse Dural Clip2023-03-17 NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and ortho

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