SMR Shoulder - Hybrid Glenoid 9013.79.510

GUDID 08033390121323

Glenoid Drill Guide SMALL

LIMACORPORATE SPA

Surgical drill guide, reusable
Primary Device ID08033390121323
NIH Device Record Keyd7b91c26-e828-4e15-ae00-1b5804997774
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMR Shoulder - Hybrid Glenoid
Version Model NumberGlenoid Drill Guide
Catalog Number9013.79.510
Company DUNS432066322
Company NameLIMACORPORATE SPA
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390121323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390121323]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-04-06
Device Publish Date2017-07-05

On-Brand Devices [SMR Shoulder - Hybrid Glenoid]

08033390124232Reverse Baseplate Extractor
08033390124225Glenosphere Extractor Handle
08033390124188Glenosphere Dia. 40 mm - Ecc. 40mm Extraction Insert
08033390124171Ecc Glenosphere Dia. 36mm Extraction Insert
08033390124164Glenosphere Dia. 36 mm Extraction Insert
08033390124157Glenosphere Impactor - Orienter
08033390123815Baseplate Extractor
08033390123785Removal Guide LARGE
08033390123778Removal Guide STD
08033390123761Removal Guide SMALL
08033390121422Glenoid Positioner LARGE
08033390121415Glenoid Positioner STD
08033390121392Glenoid Positioner SMALL
08033390124065Drill Guide for Reverse Baseplate
08033390123839Guide for Conversion Glenoid Reamer
08033390121347Glenoid Drill Guide LARGE
08033390121330Glenoid Drill Guide STD
08033390121323Glenoid Drill Guide SMALL
08033390180566Removal Drill Guide
08033390180542Removal Guide LARGE LOW
08033390180528Removal Guide STD LOW
08033390180504Removal Guide SMALL LOW
08033390180481Removal Drill +2mm
08033390180412Removal Drill +0mm
08033390124515Reverse Baseplate Orienter
08033390124256K-Wire Positioning Jig for TT Peg
08033390124201Glenosphere Insertion Guide
08033390121408Central Peg Protector
08033390121385Cement Compactor LARGE
08033390121378Cement Compactor STD
08033390121361Cement Compactor SMALL
08033390121316Compactor L
08033390121309Compactor S

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