P.F.C. SIGMA 158196113

GUDID 10603295065005

P.F.C. SIGMA PATELLA ROUND DOME 3 POST 41mm CEMENTED

DEPUY (IRELAND)

Polyethylene patella prosthesis

• Primary Device ID: 10603295065005
• NIH Device Record Key: ca049c5c-2739-4650-bb40-b0da60fcf9b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.F.C. SIGMA
• Version Model Number: 1581-96-113
• Catalog Number: 158196113
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• Device Count: 1
• DM Exempt: false
• 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295065005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884796

FDA Product Code

• NJL: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-03-24

On-Brand Devices [P.F.C. SIGMA]

• 10603295065005: P.F.C. SIGMA PATELLA ROUND DOME 3 POST 41mm CEMENTED
• 10603295064992: P.F.C. SIGMA PATELLA ROUND DOME 3 POST 38mm CEMENTED
• 10603295064985: P.F.C. SIGMA PATELLA ROUND DOME 3 POST 35mm CEMENTED
• 10603295064978: P.F.C. SIGMA PATELLA ROUND DOME 3 POST 32mm CEMENTED
• 10603295064961: P.F.C. SIGMA PATELLA OVAL DOME 3-POST 41mm CEMENTED
• 10603295064954: P.F.C. SIGMA PATELLA OVAL DOME 3-POST 38mm CEMENTED
• 10603295064947: P.F.C. SIGMA PATELLA OVAL DOME 3-POST 35mm CEMENTED
• 10603295064930: P.F.C. SIGMA PATELLA OVAL DOME 3-POST 32mm CEMENTED