BIOPRO MEMORY STAPLE 13X15-1.5X1.5MM PKG

GUDID M209227740

BIOPRO MEMORY STAPLE 13X15-1.5X1.5MM PKG

BIOPRO, INC.

Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: M209227740
• NIH Device Record Key: f0e9f9f2-3787-461a-8e45-bebd8c946850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPRO MEMORY STAPLE 13X15-1.5X1.5MM PKG
• Version Model Number: 22774
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M209227740 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-23
• Device Publish Date: 2020-06-01

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• M209230820 - MTP FUSION PLATE 0 DEGREE, RIGHT: 2024-04-03
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• M20923085 - MTP FUSION PLATE, NARROW 5 DEGREE, LEFT: 2024-04-03
• M209230860 - MTP FUSION PLATE, NARROW 5 DEGREE, RIGHT: 2024-04-03