Optimized Positioning System (OPS) Plan

GUDID 09351327000077

OPS Plan

OPTIMIZED ORTHO PTY LTD

Radiology DICOM image processing application software
Primary Device ID09351327000077
NIH Device Record Keydb34261a-97d3-4d87-85b0-ce55c4b63e80
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptimized Positioning System (OPS) Plan
Version Model Number1250-1300
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109351327000077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-07
Device Publish Date2019-04-23

On-Brand Devices [Optimized Positioning System (OPS) Plan]

09351327000091OPS Plan V.2.0
09351327000077OPS Plan

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