Rod Pusher

GUDID 07290115935509

PREMIA SPINE LTD

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID07290115935509
NIH Device Record Keyf43f4e90-c122-4dfb-b5d3-76854a9fc926
Commercial Distribution StatusIn Commercial Distribution
Brand NameRod Pusher
Version Model Number86604
Company DUNS649220779
Company NamePREMIA SPINE 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290115935509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


[07290115935509]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-09
Device Publish Date2024-10-01

On-Brand Devices [Rod Pusher]

0729011593550986604
0729011593543183203

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