Acetabular Cups 9058.85.355

GUDID 08033390114615

Neutral Trial Liner Head Dia.28mm #SMALL

LIMACORPORATE SPA

Acetabulum prosthesis trial, reusable

• Primary Device ID: 08033390114615
• NIH Device Record Key: bf563090-65ec-4d94-ace5-d49ccfe9d363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acetabular Cups
• Version Model Number: Trial Liner
• Catalog Number: 9058.85.355
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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 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	08033390114615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112898

FDA Product Code

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

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

[08033390114615]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-07-05
• Device Publish Date: 2016-11-26

On-Brand Devices [Acetabular Cups]

• 08033390114646: Neutral Trial Liner Head Dia.32mm #SMALL
• 08033390114615: Neutral Trial Liner Head Dia.28mm #SMALL
• 08033390114691: Neutral Trial Liner Head Dia.40mm #LARGE
• 08033390114684: Neutral Trial Liner Head Dia.36mm #LARGE
• 08033390114677: Neutral Trial Liner Head Dia.36mm #MEDIUM
• 08033390114660: Neutral Trial Liner Head Dia.32mm #LARGE
• 08033390114653: Neutral Trial Liner Head Dia.32mm #MEDIUM
• 08033390114639: Neutral Trial Liner Head Dia.28mm #LARGE
• 08033390114622: Neutral Trial Liner Head Dia.28mm #MEDIUM