MEMORY STAPLE 11 X 15 X 131.5 X 1.5MM

GUDID 00810012480475

BIOPRO, INC.

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: 00810012480475
• NIH Device Record Key: 04e15faf-4fff-4b44-9191-d92683ec2522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEMORY STAPLE 11 X 15 X 131.5 X 1.5MM
• Version Model Number: 17634
• 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	00810012480475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061798

FDA Product Code

• JDR: Staple, Fixation, Bone

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: 2019-06-13
• Device Publish Date: 2019-06-05

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