PE – cup insert 10°

GUDID 04048844006969

implantcast GmbH

Constrained polyethylene acetabular liner

• Primary Device ID: 04048844006969
• NIH Device Record Key: f67103c4-0653-4bfe-a5f3-3afb84b9ccda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PE – cup insert 10°
• Version Model Number: 02804552
• Company DUNS: 324369826
• Company Name: implantcast GmbH
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04048844006969 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• Device Publish Date: 2018-08-31

On-Brand Devices [PE – cup insert 10°]

• 04048844355708: 02803139
• 04048844006969: 02804552
• 04048844006952: 02804548
• 04048844006846: 02803152
• 04048844006839: 02803148
• 04048844006822: 02803144