My Spine Pedicle Screw Placement Guides

GUDID 07630030856419

Screwdriver sleeve

Medacta International SA

Orthopaedic implantation sleeve, single-use
Primary Device ID07630030856419
NIH Device Record Key4dfcbb55-66de-41ab-a09a-6697b7351c87
Commercial Distribution StatusIn Commercial Distribution
Brand NameMy Spine Pedicle Screw Placement Guides
Version Model Number7.0070
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
GS107630030856419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630030856419]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-11-18

On-Brand Devices [My Spine Pedicle Screw Placement Guides]

07630030856761MySpine drill guide L05 STERILE
07630030856754MySpine drill guide L05
07630030856747MySpine drill guide L04 STERILE
07630030856730MySpine drill guide L04
07630030856723MySpine drill guide L03 STERILE
07630030856716MySpine drill guide L03
07630030856709MySpine drill guide L02 STERILE
07630030856693MySpine drill guide L02
07630030856686MySpine drill guide L01 STERILE
07630030856679MySpine drill guide L01
07630030856662MySpine drill guide T12 STERILE
07630030856655MySpine drill guide T12
07630030856648MySpine drill guide T11 STERILE
07630030856631MySpine drill guide T11
07630030856624MySpine drill guide T10 STERILE
07630030856617MySpine drill guide T10
07630030856600MySpine drill guide T09 STERILE
07630030856594MySpine drill guide T09
07630030856587MySpine drill guide T08 STERILE
07630030856570MySpine drill guide T08
07630030856563MySpine drill guide T07 STERILE
07630030856556MySpine drill guide T07
07630030856549MySpine drill guide T06 STERILE
07630030856532MySpine drill guide T06
07630030856525MySpine drill guide T05 STERILE
07630030856518MySpine drill guide T05
07630030856501MySpine drill guide T04 STERILE
07630030856495MySpine drill guide T04
07630030856488MySpine drill guide T03 STERILE
07630030856471MySpine drill guide T03
07630030856464MySpine drill guide T02 STERILE
07630030856457MySpine drill guide T02
07630030856440MySpine drill guide T01 STERILE
07630030856433MySpine drill guide T01
07630030856426Screwdriver sleeve STERILE
07630030856419Screwdriver sleeve
07630030856402Lumbar probe sleeve STERILE
07630030856396Lumbar probe sleeve
07630030856389Thoracic probe sleeve STERILE
07630030856372Thoracic probe sleeve
07630030856365Awl sleeve STERILE
07630030856358Awl sleeve
07630030856341MySpine vertebra L05 STERILE
07630030856334MySpine vertebra L05
07630030856327MySpine vertebra L04 STERILE
07630030856310MySpine vertebra L04
07630030856303MySpine vertebra L03 STERILE
07630030856297MySpine vertebra L03
07630030856280MySpine vertebra L02 STERILE
07630030856273MySpine vertebra L02

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