VersaLink Rod Inserter

GUDID 07290115932584

PREMIA SPINE LTD

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID07290115932584
NIH Device Record Key5da05009-030b-4455-990f-4e7654a4e0c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersaLink Rod Inserter
Version Model Number82601
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
GS107290115932584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

Moist Heat or Steam Sterilization


[07290115932584]

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 [VersaLink Rod Inserter]

0729011593554783208
0729011593258482601

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.