Peridot-TD Intervertebral body fusion system

GUDID 08809987236295

GBS Commonwealth Co.,Ltd.

Metallic spinal interbody fusion cage
Primary Device ID08809987236295
NIH Device Record Keye1af265f-5ccb-4ab3-8c47-1ba6d098b185
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeridot-TD Intervertebral body fusion system
Version Model NumberL451-B5C6
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
GS108809987236295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

Moist Heat or Steam Sterilization


[08809987236295]

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-TD Intervertebral body fusion system]

08800167333254L451-B5C6S
08800167333247L451-B5C4S
08800167333230L451-B5C2S
08800167333223L451-B5C0S
08800167333216L451-B5B6S
08800167333209L451-B5B4S
08800167333193L451-B5B2S
08800167333186L451-B5B0S
08800167333179L451-B556S
08800167333162L451-B554S
08800167333155L451-B552S
08800167333148L451-B550S
08800167333131L451-B5A6S
08800167333124L451-B5A4S
08800167333117L451-B5A2S
08800167333100L451-B5A0S
08800167333094L451-B546S
08800167333087L451-B544S
08800167333070L451-B542S
08800167333063L451-B540S
08800167333056L451-B2C6S
08800167333049L451-B2C4S
08800167333032L451-B2C2S
08800167333025L451-B2B6S
08800167333018L451-B2B4S
08800167333001L451-B2B2S
08800167332998L451-B256S
08800167332981L451-B254S
08800167332974L451-B252S
08800167332967L451-B2A6S
08800167332950L451-B2A4S
08800167332943L451-B2A2S
08800167332936L451-B246S
08800167332929L451-B244S
08800167332912L451-B242S
08800167332905L451-B8C6S
08800167332899L451-B8C4S
08800167332882L451-B8C2S
08800167332875L451-B8C0S
08800167332868L451-B8B6S
08800167332851L451-B8B4S
08800167332844L451-B8B2S
08800167332837L451-B8B0S
08800167332820L451-B856S
08800167332813L451-B854S
08800167332806L451-B852S
08800167332790L451-B850S
08800167332783L451-B8A6S
08800167332776L451-B8A4S
08800167332769L451-B8A2S

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