Centrax 6226-2-243

GUDID 07613327032017

Bipolar Duration Stabilized

Howmedica Osteonics Corp.

Femoral head bipolar component

• Primary Device ID: 07613327032017
• NIH Device Record Key: 1676fbc6-30d0-4274-bd7c-d0fc6fd1296e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centrax
• Version Model Number: 6226-2-243
• Catalog Number: 6226-2-243
• 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

• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter
• Outer Diameter: 43 Millimeter
• Lumen/Inner Diameter: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327032017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972792

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Centrax]

• 07613327032284: Bipolar Duration Stabilized
• 07613327032277: Bipolar Duration Stabilized
• 07613327032260: Bipolar Duration Stabilized
• 07613327032253: Bipolar Duration Stabilized
• 07613327032246: Bipolar Duration Stabilized
• 07613327032239: Bipolar Duration Stabilized
• 07613327032222: Bipolar Duration Stabilized
• 07613327032215: Bipolar Duration Stabilized
• 07613327032208: Bipolar Duration Stabilized
• 07613327032192: Bipolar Duration Stabilized
• 07613327032185: Bipolar Duration Stabilized
• 07613327032178: Bipolar Duration Stabilized
• 07613327032161: Bipolar Duration Stabilized
• 07613327032154: Bipolar Duration Stabilized
• 07613327032147: Bipolar Duration Stabilized
• 07613327032130: Bipolar Duration Stabilized
• 07613327032123: Bipolar Duration Stabilized
• 07613327032116: Bipolar Duration Stabilized
• 07613327032109: Bipolar Duration Stabilized
• 07613327032093: Bipolar Duration Stabilized
• 07613327032086: Bipolar Duration Stabilized
• 07613327032079: Bipolar Duration Stabilized
• 07613327032062: Bipolar Duration Stabilized
• 07613327032055: Bipolar Duration Stabilized
• 07613327032048: Bipolar Duration Stabilized
• 07613327032031: Bipolar Duration Stabilized
• 07613327032024: Bipolar Duration Stabilized
• 07613327032017: Bipolar Duration Stabilized
• 07613327032000: Bipolar Duration Stabilized
• 07613327031997: Bipolar Duration Stabilized
• 07613327031980: Bipolar Duration Stabilized
• 07613327031973: Bipolar Duration Stabilized
• 07613327031966: Bipolar Duration Stabilized