Peridot Intervertebral body fusion system

GUDID 08800044793201

GBS Commonwealth Co.,Ltd.

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID08800044793201
NIH Device Record Key9413da6a-3594-4abb-9ec4-1613373b4ee5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeridot Intervertebral body fusion system
Version Model NumberL331-0136
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
GS108800044793201 [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

[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


[08800044793201]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-08
Device Publish Date2020-12-31

On-Brand Devices [Peridot Intervertebral body fusion system]

08800044793683L331-8035
08800044793676L331-8034
08800044793669L331-8033
08800044793652L331-8032
08800044793645L331-8031
08800044793638L331-8030
08800044793621L331-8039
08800044793614L331-8038
08800044793164L331-0035
08800044793157L331-0034
08800044793140L331-0033
08800044793133L331-0032
08800044793126L331-0031
08800044793119L331-0030
08800044793102L331-0039
08800044793096L331-0038
08800044793089L331-0037
08800044770141L312-0053
08800044770134L312-0052
08800044770127L312-0051
08800044770110L312-0050
08800044770103L312-0059
08800044770097L312-0058
08800044769404L311-8053
08800044769398L311-8052
08800044769381L311-8051
08800044769374L311-8050
08800044769367L311-8059
08800056288375L364-F90J
08800056288368L364-F90H
08800056288351L364-F90G
08800056288344L364-F90F
08800056288337L364-F90E
08800056288320L364-F90D
08800056288313L364-F90C
08800056288306L364-F90B
08800056288290L364-F90A
08800056288283L364-E90J
08800056288276L364-E90H
08800056288269L364-E90G
08800056288252L364-E90F
08800056288245L364-E90E
08800056288238L364-E90D
08800056288221L364-E90C
08800056288214L364-E90B
08800056288207L364-E90A
08800056288191L364-E908
08800056288184L364-E907
08800056288177L364-E906
08800056288160L364-E905

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