DuraFuse Dural Clip

GUDID 00860007130403

NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and orthopedic spine procedures. NeuraMedica Dural Clips are 3mm wide by 4.6mm long. They are applied using a reusable stainless steel applier. The NeuraMedica Applier is a separately-supplied reusable instrument.

Neuramedica Inc.

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Primary Device ID00860007130403
NIH Device Record Key61994351-c46f-47f1-b20d-aebc0f6376b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraFuse Dural Clip
Version Model NumberDC-501
Company DUNS079885939
Company NameNeuramedica Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Safe
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100860007130403 [Primary]

FDA Product Code

FZPClip, Implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-17
Device Publish Date2023-03-09

Devices Manufactured by Neuramedica Inc.

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 Clip2023-03-17NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and orthopedic spine procedures. NeuraMedica Dural Clips are 3mm wide by 4.6mm long. They are applied using a reusable stainless steel applier. The NeuraMedica Applier is a separately-supplied reusable instrument.
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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