SMR Shoulder 9013.79.583

GUDID 08033390214599

SMR Shoulder - Glenosph. Dia. 42-Ecc.42 Extract. Insert

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable
Primary Device ID08033390214599
NIH Device Record Key08811bdf-3bfb-4d19-9eb9-d618b749dfa2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMR Shoulder
Version Model Number9013.79.583
Catalog Number9013.79.583
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 Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390214599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


[08033390214599]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-25
Device Publish Date2022-03-17

On-Brand Devices [SMR Shoulder]

08033390152068Reverse Adaptor Sleeve
08033390122412Adaptor for stem extractor
08033390122320Glenosphere Extractor
08033390122313Glenosphere Impactor
08033390120784Long Stem for Glenosphere Extractor
080333901194983 Pegs Removal Guide #LARGE - SMR Shoulder
080333901194813 Pegs Removal Guide #SMALL - SMR Shoulder
080333901194743 Pegs Removal Guide #STD - SMR Shoulder
080333901194673 Pegs Removal Guide #X-SMALL - SMR Shoulder
08033390115469Glenoid Impactor CMI
08033390099035Glenosphere Impactor-Extractor
08033390098892Reverse Prosthesis Inserter
08033390098328Body Stopper
08033390097598Expansion Extractor
08033390097581Universal Stem for Extractor
08033390097574Threaded Extractor
08033390095426TT Metal Back Impactor
08033390094863Baseplate Extractor
08033390094856SMALL-R Baseplate Extractor
08033390038911Body Stopper
08033390038317Extractor for Metal Back
08033390023528Glenosphere Impactor-Extractor
08033390023429Expansion Extractor
08033390023368Universal Stem for Extractor
08033390023351Extractor for Humeral Body
08033390022989Prosthesis Introducer
08033390022972Extractor for Small-R Metal Back
08033390128568SMR Shoulder - Humeral Body Trial Screw
08033390118194Bone Graft Instrument Set - K-Wire Positioning Jig STD 15°
08033390118187Bone Graft Instrument Set - K-Wire Positioning Jig S 15°
080333901143493 Pegs Glenoid Cement Compactor X-SMALL
08033390114295Mask XS for K-Wire Insertion
08033390108782Bone Graft Instrument Set - Head K-Wire Positioner
08033390103213Trial Mini Stem with Quick Connect. Dia.13 mm
08033390103206Trial Mini Stem with Quick Connect. Dia.12 mm
08033390103190Trial Mini Stem with Quick Connect. Dia.11 mm
08033390095402Mask STD 20° for K-Wire Insertion
08033390095372Mask STD for K-Wire Insertion
08033390095358Mask S 20° for K-Wire Insertion
08033390095327Mask S for K-Wire Insertion
08033390095297Compactor SMALL/STD/LARGE #X-LONG
08033390095280Compactor SMALL/STD/LARGE #LONG
08033390095273Compactor SMALL/STD/LARGE #MEDIUM
08033390095266Compactor SMALL/STD/LARGE #SHORT
08033390095259Compactor SMALL-R #X-LONG
08033390095242Compactor SMALL-R #LONG
08033390095235Compactor SMALL-R #MEDIUM
08033390095228Compactor SMALL-R #SHORT
08033390095204Reamer SMALL/STD/LARGE #X-LONG
08033390095198Reamer SMALL/STD/LARGE #LONG

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.