Peridot-PT Anterior Cervical Intervertebral body fusion system

GUDID 08800167334916

GBS Commonwealth Co.,Ltd.

Metallic spinal interbody fusion cage
Primary Device ID08800167334916
NIH Device Record Key98bdbb9c-4c73-4c7b-ad8d-559e15105a4e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeridot-PT Anterior Cervical Intervertebral body fusion system
Version Model NumberC417-2005
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
GS108800167334916 [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

[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


[08800167334916]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-29
Device Publish Date2024-01-19

On-Brand Devices [Peridot-PT Anterior Cervical Intervertebral body fusion system ]

08800167324771C41C-1105S
08800167324764C41C-1106S
08800167324757C41C-1107S
08800167324740C41C-1108S
08800167324733C41C-1109S
08800167324726C41C-1110S
08800167324719C41C-1111S
08800167324702C41C-1112S
08800167324696C41C-1113S
08800167324689C41C-1114S
08800167324672C41C-1115S
08800167324665C41C-1405S
08800167324658C41C-1406S
08800167324641C41C-1407S
08800167324634C41C-1408S
08800167324627C41C-1409S
08800167324610C41C-1410S
08800167324603C41C-1411S
08800167324597C41C-1412S
08800167324580C41C-1413S
08800167324573C41C-1414S
08800167324566C41C-1415S
08800167324559C41C-1705S
08800167324542C41C-1706S
08800167324535C41C-1707S
08800167324528C41C-1708S
08800167324511C41C-1709S
08800167324504C41C-1710S
08800167324498C41C-1711S
08800167324481C41C-1712S
08800167324474C41C-1713S
08800167324467C41C-1714S
08800167324450C41C-1715S
08800167324443C41C-2005S
08800167324436C41C-2006S
08800167324429C41C-2007S
08800167324412C41C-2008S
08800167324405C41C-2009S
08800167324399C41C-2010S
08800167324382C41C-2011S
08800167324375C41C-2012S
08800167324368C41C-2013S
08800167324351C41C-2014S
08800167324344C41C-2015S
08800167324337C410-1105S
08800167324320C410-1106S
08800167324313C410-1107S
08800167324306C410-1108S
08800167324290C410-1109S
08800167324283C410-1110S

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