Ceramic femoral head RM30660003

GUDID 03662200028436

SOC ETUDES RECHERCHES FABRICATION

Ceramic femoral head prosthesis

• Primary Device ID: 03662200028436
• NIH Device Record Key: 09306efe-9872-47ca-a982-4a4f222d66ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramic femoral head
• Version Model Number: D28-CL
• Catalog Number: RM30660003
• Company DUNS: 282651413
• Company Name: SOC ETUDES RECHERCHES FABRICATION
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662200004126 [Previous]
GS1	03662200028436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223745

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-01
• Device Publish Date: 2024-10-24

On-Brand Devices [Ceramic femoral head]

• 03662200004126: D28-CL
• 03662200004119: D28-CM
• 03662200004102: D28-CC
• 03662200028436: D28-CL
• 03662200028429: D28-CM
• 03662200028412: D28-CC