Dome Hole Plug 2060-0000-1

GUDID 07613327037067

Acetabular Dome Hole Plug

Howmedica Osteonics Corp.

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• Primary Device ID: 07613327037067
• NIH Device Record Key: 409787bb-b1a6-44a9-9d04-5d0ca01c3a01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dome Hole Plug
• Version Model Number: 2060-0000-1
• Catalog Number: 2060-0000-1
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327037067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942809

FDA Product Code

• JDL: Prosthesis, hip, semi-constrained (metal cemented acetabular component)

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

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