MEMORY STAPLE 7 X 51.2 X 1.2MM/XSM

GUDID 00810012480505

BIOPRO, INC.

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: 00810012480505
• NIH Device Record Key: f3da4b50-1c0f-4188-b765-eaf193c9ddf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEMORY STAPLE 7 X 51.2 X 1.2MM/XSM
• Version Model Number: 17637
• 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	00810012480505 [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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