Peridot-PT Intervertebral body fusion system

GUDID 08809987224674

GBS Commonwealth Co.,Ltd.

Metallic spinal interbody fusion cage
Primary Device ID08809987224674
NIH Device Record Keyd00a9d98-216d-4f4d-af53-0f29f5b4e17a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeridot-PT Intervertebral body fusion system
Version Model NumberL656-05C8S
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809987224674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 Intervertebral body fusion system ]

08800167328755L541-F90IS
08800167328748L541-F90GS
08800167328731L541-F90ES
08800167328724L541-D90GS
08800167328717L541-D90ES
08800167328700L541-D90CS
08800167328694L541-D90AS
08800167328687L541-C90ES
08800167328670L541-C90CS
08800167328663L541-C90AS
08800167328656L541-C906S
08800167328649L541-C904S
08800167328632L541-B90CS
08800167328625L541-B90AS
08800167328618L541-B906S
08800167328601L541-B904S
08800167328595L541-B902S
08800167328588L541-890AS
08800167328571L541-8906S
08800167328564L541-8904S
08800167328557L541-8902S
08800167328540L541-8900S
08800167328533L541-F24IS
08800167328526L541-F24GS
08800167328519L541-F24ES
08800167328502L541-F24CS
08800167328496L541-D24ES
08800167328489L541-D24CS
08800167328472L541-D24AS
08800167328465L541-D246S
08800167328458L541-C24CS
08800167328441L541-C24AS
08800167328434L541-C246S
08800167328427L541-C244S
08800167328410L541-B24AS
08800167328403L541-B246S
08800167328397L541-B244S
08800167328380L541-B242S
08800167328373L541-824AS
08800167328366L541-8246S
08800167328359L541-8244S
08800167328342L541-8242S
08800167328335L541-8240S
08800167328328L531-80C5S
08800167328311L531-80C4S
08800167328304L531-80C3S
08800167328298L531-80C2S
08800167328281L531-80C1S
08800167328274L531-80C0S
08800167328267L531-80C9S

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