Optimized Ortho Positioning (OPS) Femoral

GUDID 09351327000039

Patient Specific Femoral Guide

OPTIMIZED ORTHO PTY LTD

Custom-made orthopaedic surgical guide, non-sterile Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide
Primary Device ID09351327000039
NIH Device Record Key22086808-05b1-4e77-8692-bac7cff334f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptimized Ortho Positioning (OPS) Femoral
Version Model Number1250-1100
Company DUNS745735175
Company NameOPTIMIZED ORTHO PTY 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109351327000039 [Primary]

FDA Product Code

PBFOrthopaedic Surgical Planning And Instrument Guides

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


[09351327000039]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-22
Device Publish Date2019-04-12

On-Brand Devices [Optimized Ortho Positioning (OPS) Femoral]

09351327000046Trial Femoral Head
09351327000039Patient Specific Femoral Guide

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