Bearing and Axle Bushing Assembly - Standard Elbow C-M113-1-301

GUDID 37613327590075

Howmedica Osteonics Corp.

Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis Coated elbow humerus prosthesis

• Primary Device ID: 37613327590075
• NIH Device Record Key: e477eb43-a3b7-4b4c-96ba-cb16661a09ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bearing and Axle Bushing Assembly - Standard Elbow
• Version Model Number: C-M113-1-301
• Catalog Number: C-M113-1-301
• 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	07613327590074 [Primary]
GS1	37613327590075 [Package]; Contains: 07613327590074; Package: pack [1 Units]; In Commercial Distribution
GS1	57613327590079 [Package]; Package: case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980502

FDA Product Code

• JDC: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

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: 2022-03-31
• Device Publish Date: 2022-03-23

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