RATCHET HANDLE WITH AO CONNECT

GUDID 00810012485760

BIOPRO, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00810012485760
• NIH Device Record Key: b40031bf-d9d7-46ff-b15f-75092f35e4cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RATCHET HANDLE WITH AO CONNECT
• Version Model Number: 22293
• 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: false
• Manufacturing Date: true
• 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	00810012485760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083490

FDA Product Code

• HWA: Impactor

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: 2019-06-20
• Device Publish Date: 2019-06-12

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