Peridot Anterior Cervical Intervertebral Body Fusion System

GUDID 08800113304208

GBS Commonwealth Co.,Ltd.

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Primary Device ID08800113304208
NIH Device Record Keye0732cb9-4e76-4f47-9a8a-68660afeca6f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeridot Anterior Cervical Intervertebral Body Fusion System
Version Model NumberC223-1406
Company DUNS694609156
Company NameGBS Commonwealth Co.,Ltd.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800113304208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


[08800113304208]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [Peridot Anterior Cervical Intervertebral Body Fusion System]

08800113310551C24A-1714
08800113310544C24A-1713
08800113310537C24A-1712
08800113310520C24A-1711
08800113310513C24A-1710
08800113310506C24A-1709
08800113310490C24A-1708
08800113310483C24A-1707
08800113310476C24A-1706
08800113310469C24A-1705
08800113310452C24A-1415
08800113310445C24A-1414
08800113310438C24A-1413
08800113310421C24A-1412
08800113310414C24A-1411
08800113310407C24A-1410
08800113310391C24A-1409
08800113310384C24A-1408
08800113310377C24A-1407
08800113310360C24A-1406
08800113310353C24A-1405
08800113310346C24A-1115
08800113310339C24A-1114
08800113310322C24A-1113
08800113310315C24A-1112
08800113310308C24A-1111
08800113310292C24A-1110
08800113310285C24A-1109
08800113310278C24A-1108
08800113310261C24A-1107
08800113310254C24A-1106
08800113310247C24A-1105
08800113310230C247-2015
08800113310223C247-2014
08800113310216C247-2013
08800113310209C247-2012
08800113310193C247-2011
08800113310186C247-2010
08800113310179C247-2009
08800113310162C247-2008
08800113310155C247-2007
08800113310148C247-2006
08800113310131C247-2005
08800113310124C247-1715
08800113310117C247-1714
08800113310100C247-1713
08800113310094C247-1712
08800113310087C247-1711
08800113310070C247-1710
08800113310063C247-1709

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