LARGE STAPLE PUNCH

GUDID 00810012483827

BIOPRO, INC.

Bone awl

• Primary Device ID: 00810012483827
• NIH Device Record Key: 3a8693b0-a84f-4764-ad9b-bd35cb5657f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LARGE STAPLE PUNCH
• Version Model Number: 17653
• 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	00810012483827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061798

FDA Product Code

• HWJ: Awl

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: 2019-06-18
• Device Publish Date: 2019-06-10

On-Brand Devices [LARGE STAPLE PUNCH]

• M209176530: 17653
• 00810012483827: 17653