P.F.C. SIGMA RPF 950015

GUDID 10603295224037

P.F.C. SIGMA FEMORAL RPF CEMENTED SIZE 4 LEFT

DEPUY INTERNATIONAL LTD

Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic Uncoated knee femur prosthesis, metallic

• Primary Device ID: 10603295224037
• NIH Device Record Key: 93173e14-5520-4bce-96a2-3606a81769d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.F.C. SIGMA RPF
• Version Model Number: 95-0015
• Catalog Number: 950015
• 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	10603295224037 [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