HLS Noetos GDF442

GUDID 05056139206863

HLS Noetos fixed tibial insert PS - thickness 15mm Size 2

CORIN LTD

Tibial insert

• Primary Device ID: 05056139206863
• NIH Device Record Key: 89fa832b-1f63-4674-b57e-8d26490b1c99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HLS Noetos
• Version Model Number: GDF442
• Catalog Number: GDF442
• Company DUNS: 295437313
• Company Name: CORIN LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +330456608978
• Email: severine.siracusa@coringroup.c

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056139206863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013906

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[05056139206863]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-28
• Device Publish Date: 2018-08-28

On-Brand Devices [HLS Noetos]

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