CEMENTED CUPS 5615.50.015

GUDID 08033390012652

Cemented cups (UHMWPE) Dia. 46 for head dia32mm

LIMACORPORATE SPA

Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis Polyethylene acetabulum prosthesis

• Primary Device ID: 08033390012652
• NIH Device Record Key: ea7b7df9-12d4-4ede-8bde-24a9bd88a1a2
• Commercial Distribution Discontinuation: 2023-11-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CEMENTED CUPS
• Version Model Number: Standard Cup
• Catalog Number: 5615.50.015
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390012652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112158

FDA Product Code

• KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

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: 2023-11-29
• Device Publish Date: 2015-07-31

On-Brand Devices [CEMENTED CUPS]

• 08033390013062: Cemented protruded acet. Cups 20°(UHMWPE) Dia. 48 for head dia. 32 mm
• 08033390013055: Cemented protruded acet. Cups 20°(UHMWPE) Dia. 46 for head dia. 32 mm
• 08033390012669: Cemented cups (UHMWPE) Dia. 48 for head dia32mm
• 08033390012652: Cemented cups (UHMWPE) Dia. 46 for head dia32mm