Patellar Pegs Drill Guide 9065.95.215

GUDID 08033390110587

Patellar Pegs Drill Guide - PHYSICA

LIMACORPORATE SPA

Surgical drill guide, reusable
Primary Device ID08033390110587
NIH Device Record Keybb1d280c-6d6b-45d6-aa8e-44b300ab6399
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatellar Pegs Drill Guide
Version Model NumberPatellar Pegs Drill Guide
Catalog Number9065.95.215
Company DUNS432066322
Company NameLIMACORPORATE SPA
Device Count1
DM Exempttrue
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 Datefalse
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
GS108033390110587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390110587]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-04-06
Device Publish Date2016-08-05

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08033390025485 - Instrument Set2026-02-09 Impactor for Cemented Cups Dia.28mm - Acetabular Cup
08033390025492 - Instrument Set2026-02-09 Impactor for Cemented Cups Dia.32mm - Acetabular Cup
08033390025683 - SPH Cups2026-02-09 Liner Impactor for Dia=28mm Heads - Acetabular Cup
08033390025690 - SPH Cups2026-02-09 Liner Impactor for Dia=32mm Heads - Acetabular Cup
08033390026925 - Instrument Set2026-02-09 Beater for Humeral Heads - SMR Shoulder

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