ODC S-1539-HA54

GUDID 07613327039184

Acetabular Cup

Howmedica Osteonics Corp.

Polyethylene acetabulum prosthesis

• Primary Device ID: 07613327039184
• NIH Device Record Key: fd25b5f9-4597-42a9-b007-46b96364b0ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ODC
• Version Model Number: S-1539-HA54
• Catalog Number: S-1539-HA54
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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: 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

• Lumen/Inner Diameter: 26 Millimeter
• Outer Diameter: 54 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327039184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K803192

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [ODC]

• 07613327039184: Acetabular Cup
• 07613327039177: Acetabular Cup
• 07613327032598: Acetabular Cup
• 07613327032581: Acetabular Cup