BioBall DELTA™ Ceramic Head HM50032

GUDID 04048266025463

ISO 6474-2 sterile

Merete GmbH

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 04048266025463
• NIH Device Record Key: 4a2d333d-3e2b-47ab-9dfc-2fe040f0377d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioBall DELTA™ Ceramic Head
• Version Model Number: 32
• Catalog Number: HM50032
• Company DUNS: 313267265
• Company Name: Merete 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: true
• 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

Customer Support Contacts

• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: 630-613-7182
• Email: service@merete.medical.com

Device Dimensions

• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266025463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141377

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-10-15

On-Brand Devices [BioBall DELTA™ Ceramic Head]

• 04048266025470: ISO 6474-2 sterile
• 04048266025463: ISO 6474-2 sterile
• 04048266025456: ISO 6474-2 sterile