BioPro Bipolar Head 40mm

GUDID M209181320

BIOPRO, INC.

Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: M209181320
• NIH Device Record Key: 88045d9a-ecce-4c9b-8eff-ddabd8a3356b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPro Bipolar Head 40mm
• Version Model Number: 18132
• Company DUNS: 618749857
• Company Name: BIOPRO, INC.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M209181320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100761

FDA Product Code

• KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-09-16

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• M209178010 - THUMB MOD HEAD TITANIUM 12MM+2: 2024-07-08