Ring Nut Inserter

GUDID 07290115931808

PREMIA SPINE LTD

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID07290115931808
NIH Device Record Keyae6fdb85-2b61-4674-9043-74f958d9a681
Commercial Distribution StatusIn Commercial Distribution
Brand NameRing Nut Inserter
Version Model Number82594
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
GS107290115931808 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

Moist Heat or Steam Sterilization


[07290115931808]

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

Devices Manufactured by PREMIA SPINE LTD

07290115935264 - PER System 60 2024-10-18 PER System 60
07290115935271 - PER System 752024-10-18 PER System 75
07290115935332 - PER System 502024-10-18 PER System 50
07290115935561 - Distractor2024-10-18
07290115931808 - Ring Nut Inserter2024-10-09
07290115931808 - Ring Nut Inserter2024-10-09
07290115932485 - Ring Nut Loading Base2024-10-09
07290115932515 - Versalink Nut Counter Torque2024-10-09
07290115932553 - VersaLink Bender2024-10-09

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