Versalink Torque Limiter

GUDID 07290115935554

PREMIA SPINE LTD

Surgical instrument torque limiter
Primary Device ID07290115935554
NIH Device Record Key6512818b-ff3c-41ab-a52d-515e3ec65236
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersalink Torque Limiter
Version Model Number87205
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
GS107290115935554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

Moist Heat or Steam Sterilization


[07290115935554]

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 Torque Limiter]

0729011593555487205
0729011593264587206

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