PROCOTYL PHA04416

GUDID PHA04416

FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M

Microport Orthopedics Inc.

Ceramic femoral head prosthesis

• Primary Device ID: PHA04416
• NIH Device Record Key: effbf74b-5b22-4caf-813a-000954db1849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROCOTYL
• Version Model Number: PHA04416
• Catalog Number: PHA04416
• Company DUNS: 079118736
• Company Name: Microport Orthopedics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com

Device Dimensions

• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M684PHA044161 [Primary]
HIBCC	PHA04416 [Direct Marking]

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, 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: 2020-09-09
• Device Publish Date: 2015-10-20

On-Brand Devices [PROCOTYL]

• PHA04424: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 40 L
• PHA04422: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 40 M
• PHA04420: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 40 S
• PHA04418: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L
• PHA04416: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M
• PHA04414: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S
• PHA04412: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L
• PHA04410: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M
• PHA04408: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 S
• PHA04406: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L
• PHA04404: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M
• PHA04402: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S