OPS

GUDID 09351327000688

Reamer Adaptor Stryker

OPTIMIZED ORTHO PTY LTD

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID09351327000688
NIH Device Record Key06904078-d7ef-4742-af5d-b4a13e63f9b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPS
Version Model Number1248-0071
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS109351327000688 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09351327000688]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-24
Device Publish Date2020-02-14

On-Brand Devices [OPS]

09351327000831Impactor Canister Dual Adaptor
09351327000824Curved Guide Handle Post
09351327000817Curved Guide Handle
09351327000688Reamer Adaptor Stryker
09351327000671Canister Clamp
09351327000664Reference Post
09351327000800T-Handle Hex Key
09351327000770Impactor Canister Adaptor 45mm
09351327000763Short Curved Guide Handle Screwdriver
09351327000756Short Curved Guide Handle Screw
09351327000749Long Curved Guide Handle
09351327000732Short Curved Guide Handle
09351327000725Reference Arm Long
09351327000718Reference Arm Short
09351327000701Right Angle Clamp
09351327000695Impactor Canister Adaptor 42.5mm

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