P.F.C. 853831

GUDID 10603295207597

P.F.C. Total Hip System FEMORAL HEAD Diameter 28mm +0 10/12 TAPER

DEPUY INTERNATIONAL LTD

Metallic femoral head prosthesis

• Primary Device ID: 10603295207597
• NIH Device Record Key: 89dab429-26d6-409f-80f0-e88f05a55dc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.F.C.
• Version Model Number: 85-3831
• Catalog Number: 853831
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295207597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K893872

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

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: 2020-04-06
• Device Publish Date: 2015-09-24

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

• 10603295207641: P.F.C. Total Hip System FEMORAL HEAD Diameter 32mm +10 10/12 TAPER
• 10603295207634: P.F.C. Total Hip System FEMORAL HEAD Diameter 32mm +5 10/12 TAPER
• 10603295207627: P.F.C. Total Hip System FEMORAL HEAD Diameter 32mm +0 10/12 TAPER
• 10603295207610: P.F.C. Total Hip System FEMORAL HEAD Diameter 28mm +5 10/12 TAPER
• 10603295207603: P.F.C. Total Hip System FEMORAL HEAD Diameter 28mm +10 10/12 TAPER
• 10603295207597: P.F.C. Total Hip System FEMORAL HEAD Diameter 28mm +0 10/12 TAPER