P.F.C. SIGMA RPF 950021

GUDID 10603295224075

P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 1.5 RIGHT

DEPUY INTERNATIONAL LTD

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 10603295224075
• NIH Device Record Key: 478b82f2-36d3-4c0e-8a46-752389a4c5f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.F.C. SIGMA RPF
• Version Model Number: 95-0021
• Catalog Number: 950021
• Company DUNS: 896498813
• Company Name: DEPUY INTERNATIONAL LTD
• 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
• 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	10603295224075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P830055

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: 5
• Public Version Date: 2020-01-23
• Device Publish Date: 2015-03-24

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

• 10603295224136: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 6 RIGHT
• 10603295224129: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 5 RIGHT
• 10603295224112: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 4 RIGHT
• 10603295224105: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 3 RIGHT
• 10603295224075: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 1.5 RIGHT
• 10603295224068: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 1 RIGHT
• 10603295224051: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 6 LEFT
• 10603295224044: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 5 LEFT
• 10603295224013: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 2.5 LEFT
• 10603295224006: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 2 LEFT
• 10603295223993: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 1.5 LEFT
• 10603295223986: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 1 LEFT
• 10603295074809: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 4N LEFT
• 10603295224099: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 2.5 RIGHT
• 10603295224082: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 2 RIGHT
• 10603295224037: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 4 LEFT
• 10603295224020: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 3 LEFT
• 10603295074816: P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 4N RIGHT
• 10603295231493: P.F.C. SIGMA RPF INSTRUMENT CASE - INSTRUMENTS
• 10603295231486: P.F.C. SIGMA RPF INSTRUMENT CASE - TRIALS
• 10603295231431: P.F.C. SIGMA RPF SPACER BLOCK 10-17.5
• 10603295231301: P.F.C. SIGMA RPF FEMORAL DISTRACTOR S-SHAPED
• 10603295231387: P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 6
• 10603295231370: P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 5
• 10603295231363: P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 4
• 10603295231356: P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 3
• 10603295231349: P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 2.5
• 10603295231332: P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 2
• 10603295231325: P.F.C. SIGMA RPF POST CUT/FEM NOTCH GUIDE SIZE 1.5