DSS HP Polyaxial pedicle screw set, Ø5 x 45mm

GUDID 04260148896927

Paradigm Spine, LLC

Spinal dynamic-stabilization system
Primary Device ID04260148896927
NIH Device Record Key40ae5779-b59a-45d9-8cfc-29aada43178f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDSS HP Polyaxial pedicle screw set, Ø5 x 45mm
Version Model NumberHPI85045
Company DUNS787874960
Company NameParadigm Spine, LLC
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260148896927 [Primary]

FDA Product Code

NQPPosterior Metal/Polymer Spinal System, Fusion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-26
Device Publish Date2015-10-01

On-Brand Devices [DSS HP Polyaxial pedicle screw set, Ø5 x 45mm ]

00426014889692HPI85045
04260148896927HPI85045

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