Zirconia Ceramic Head

GUDID 10840843100812

Femoral Head, 28MM, Ceramic

Stelkast Incorporated

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 10840843100812
• NIH Device Record Key: 1c9726e0-da0b-4d20-b517-198368bb2978
• Commercial Distribution Discontinuation: 2017-04-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Zirconia Ceramic Head
• Version Model Number: SC1405-28mm +3.5 L
• Company DUNS: 804792265
• Company Name: Stelkast Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840843100812 [Primary]

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: 3
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-10-07

On-Brand Devices [Zirconia Ceramic Head]

• 10840843106579: 32MM Femoral Head, Zirconia, Ceramic
• 10840843106562: 32MM Femoral Head, Zirconia, Ceramic
• 10840843106555: 32MM Femoral Head, Zirconia, Ceramic
• 10840843106548: 32MM Femoral Head, Zirconia, Ceramic
• 10840843100836: Femoral Head, 28MM, Ceramic, Skirted
• 10840843100829: Femoral Head, 28MM, Ceramic
• 10840843100812: Femoral Head, 28MM, Ceramic
• 10840843100805: Femoral Head, 28MM, Ceramic