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

Devices Manufactured by LIMACORPORATE SPA

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08033390269117 - MASTER SL Stem2025-08-15 MASTER SL Stem - Lateralized - Taper 12/14 #1 H.96mm
08033390269155 - H-MAX S Stem2025-08-15 H-MAX S Stem - Standard - Taper 12/14 #8 H.130mm
08033390269162 - H-MAX S Stem2025-08-15 H-MAX S Stem - Lateralized - Taper 12/14 #8 H.130mm
08033390269254 - C2 Stem2025-08-15 C2 Stem - Standard - Taper 12/14 #01 H.128mm
08033390269261 - C2 Stem2025-08-15 C2 Stem - Lateralized - Taper 12/14 #01 H.128mm
08033390298483 - MASTER SL Stem2025-08-15 MASTER SL Stem - Standard - Taper 12/14 #2 H.123mm
08033390298490 - MASTER SL Stem2025-08-15 MASTER SL Stem - Standard - Taper 12/14 #3 H.126mm

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