Zirconia Ceramic Head

GUDID 10840843100812

Femoral Head, 28MM, Ceramic

Stelkast Incorporated

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