The JASPER Spinal Fixation System60

GUDID 08800044753069

GBS Commonwealth Co.,Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08800044753069
NIH Device Record Key8b868463-a4c7-4b4c-87f4-7f324087d595
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe JASPER Spinal Fixation System60
Version Model NumberL24F-9570
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
GS108800044753069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800044753069]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-19
Device Publish Date2019-11-11

On-Brand Devices [The JASPER Spinal Fixation System60]

08800044753304L24F-0095
08800044753298L24F-0090
08800044753281L24F-0085
08800044753274L24F-0080
08800044753267L24F-0075
08800044753250L24F-0070
08800044753243L24F-0065
08800044753236L24F-0060
08800044753229L24F-0055
08800044753212L24F-0050
08800044753205L24F-0045
08800044753199L24F-0040
08800044753182L24F-0035
08800044753175L24F-0030
08800044753168L24F-95120
08800044753151L24F-95115
08800044753144L24F-95110
08800044753137L24F-95105
08800044753120L24F-95100
08800044753113L24F-9595
08800044753106L24F-9590
08800044753090L24F-9585
08800044753083L24F-9580
08800044753076L24F-9575
08800044753069L24F-9570
08800044753052L24F-9565
08800044755643L24H-6580
08800044755636L24H-6575
08800044755629L24H-6570
08800044755612L24H-6565
08800044755605L24H-6560
08800044755599L24H-6555
08800044755582L24H-6550
08800044755575L24H-6545
08800044755568L24H-6540
08800044755551L24H-6535
08800044755544L24H-6530
08800044755537L24H-6060
08800044755520L24H-6055
08800044755513L24H-6050
08800044755506L24H-6045
08800044755490L24H-6040
08800044755483L24H-6035
08800044755476L24H-6030
08800044755469L24H-5560
08800044755452L24H-5555
08800044755445L24H-5550
08800044755438L24H-5545
08800044755421L24H-5540
08800044755414L24H-5535

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