ARTICUL/EZE 136525000

GUDID 10603295033219

ARTICUL/EZE FEMORAL HEAD Diameter 32mm +17 12/14 TAPER

DEPUY (IRELAND)

Metallic femoral head prosthesis

• Primary Device ID: 10603295033219
• NIH Device Record Key: 67526036-55b0-4408-936d-6cff97ab9704
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTICUL/EZE
• Version Model Number: 1365-25-000
• Catalog Number: 136525000
• 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
• 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	10603295033219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843909
• Premarket Notification: K883460

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2019-10-04

On-Brand Devices [ARTICUL/EZE]

• 10603295033219: ARTICUL/EZE FEMORAL HEAD Diameter 32mm +17 12/14 TAPER
• 10603295033202: ARTICUL/EZE FEMORAL HEAD Diameter 32mm +13 12/14 TAPER
• 10603295033196: ARTICUL/EZE FEMORAL HEAD Diameter 32mm +9 12/14 TAPER
• 10603295033189: ARTICUL/EZE FEMORAL HEAD Diameter 32mm +5 12/14 TAPER
• 10603295033172: ARTICUL/EZE FEMORAL HEAD Diameter 32mm +1 12/14 TAPER
• 10603295517122: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 32mm plus 9
• 10603295517108: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 32mm plus 1
• 10603295506300: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 36mm plus 12
• 10603295506294: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 28mm plus 8.5
• 10603295506287: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 28mm plus 5
• 10603295505785: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 40mm plus 12
• 10603295505778: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 40mm plus 8.5
• 10603295505761: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 40mm plus 5
• 10603295505754: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 40mm plus 1.5
• 10603295505747: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 40mm minus 2
• 10603295505723: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 36mm plus 8.5
• 10603295505716: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 36mm plus 5
• 10603295505709: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 36mm plus 1.5
• 10603295505693: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 36mm minus 2
• 10603295505662: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 32mm plus 5
• 10603295505631: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 28mm plus 1.5
• 10603295503187: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 22.225mm plus 4
• 10603295503163: ARTICUL/EZE FEMORAL HEAD CERAMIC 12/14 TAPER 22.225mm plus 7