HLS Noetos GDF693

GUDID 05056139209642

HLS Noetos Femoral component PS-Right - Size 3

CORIN LTD

Uncoated knee femur prosthesis, metallic
Primary Device ID05056139209642
NIH Device Record Keyba9c9a8a-a2f2-4282-9bc2-92e2f4c60a13
Commercial Distribution StatusIn Commercial Distribution
Brand NameHLS Noetos
Version Model NumberGDF693
Catalog NumberGDF693
Company DUNS295437313
Company NameCORIN LTD
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+330456608978
Emailseverine.siracusa@coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105056139209642 [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 Steriletrue

[05056139209642]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2018-08-28

On-Brand Devices [HLS Noetos]

05056139233654Ø10 mm extraction rod
05056139224430Plug extractor
05056139224423Tibial articular surface extractor
05056139224386Tibial IM rod
05056139217173"U" jig for distal femoral cutting guides 15-18-21
05056139216411Femoral impactor
05056139216404Reamer T-handle
05056139216374Femoral intercondylar notch cutting guide
05056139216367Base plate assembly key
05056139216350Tightening key for stem
05056139216343Tibial trial stem/regular
05056139216336Tibial trial stem/small
05056139216329Trial patellar component dome Large
05056139216312Trial patellar component dome Regular
05056139216305Trial patellar component dome Small
05056139216299Trial patellar component dome Extra Small
05056139216282Trial femoral component N°6 Left
05056139216275Trial femoral component N°5 Left
05056139216268Trial femoral component N°4 Left
05056139216251Trial femoral component N°3 Left
05056139216244Trial femoral component N°2 Left
05056139216237Trial femoral component N°1 Left
05056139216220Trial femoral component N°6 Right
05056139216213Trial femoral component N°5 Right
05056139216206Trial femoral component N°4 Right
05056139216190Trial femoral component N°3 Right
05056139216183Trial femoral component N°2 Right
05056139216176Trial femoral component N°1 Right
05056139216169Trial stem Ø14mm length 30mm
05056139216152Trial stem Ø10mm length 30mm
05056139216138Trial plug standard
05056139216121Trial plug small
05056139216114Tibial trial component N°6
05056139216107Tibial trial component N°5
05056139216091Tibial trial component N°4
05056139216084Tibial trial component N°3
05056139216077Tibial trial component N°2
05056139216060Tibial trial component N°1
05056139216053Tibial trial articular surf.N°6H21mm
05056139216046Tibial trial articular surf.N°6H18mm
05056139216039Tibial trial articular surf.N°6H15mm
05056139216022Tibial trial articular surf.N°6H13mm
05056139216015Tibial trial articular surf.N°6H11mm
05056139216008Tibial trial articular surf.N°6H9mm
05056139215995Tibial trial articular surf.N°5H21mm
05056139215988Tibial trial articular surf.N°5H18mm
05056139215971Tibial trial articular surf.N°5H15mm
05056139215964Tibial trial articular surf.N°5H13mm
05056139215957Tibial trial articular surf.N°5H11mm
05056139215940Tibial trial articular surf.N°5H9mm

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