My Spine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

GUDID 07630040728355

MySpine S02 right guide sterile

Medacta International SA

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Primary Device ID07630040728355
NIH Device Record Keyef166498-4b8a-4ced-9f47-0ca4dc99105b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMy Spine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
Version Model Number7.0728S
Company DUNS488227125
Company NameMedacta International SA
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
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]
GS107630040728355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide
PQCPedicle Screw Placement Guide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

On-Brand Devices [My Spine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides]

07630971255791MySpine S02 left guide sterile
07630971255784MySpine S02 left guide
07630971255777MySpine S02 vertebra sterile
07630971255760MySpine S02 vertebra
07630040728355MySpine S02 right guide sterile
07630040728348MySpine S02 right guide

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