CEMENTED CUPS 5615.50.020

GUDID 08033390012669

Cemented cups (UHMWPE) Dia. 48 for head dia32mm

LIMACORPORATE SPA

Polyethylene acetabulum prosthesis

• Primary Device ID: 08033390012669
• NIH Device Record Key: 226079e6-a11c-4308-a87f-7760b4169f76
• Commercial Distribution Discontinuation: 2023-11-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CEMENTED CUPS
• Version Model Number: Standard Cup
• Catalog Number: 5615.50.020
• 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	08033390012669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112158

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 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