Constrictor® Mini Button Extender AB-3150

GUDID 00854629006758

Mini Extended Button to be used with Constrictor® Mini (AB-3000)

DUNAMIS MEDICAL, LLC

Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile Orthopaedic bone washer, sterile

• Primary Device ID: 00854629006758
• NIH Device Record Key: 570812db-9a02-4a0a-87d1-1f9d00874297
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Constrictor® Mini Button Extender
• Version Model Number: AB-3150
• Catalog Number: AB-3150
• Company DUNS: 079471560
• Company Name: DUNAMIS MEDICAL, LLC
• 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: false
• Expiration Date: true
• 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	00854629006758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191319

FDA Product Code

• HTN: Washer, Bolt Nut

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: 2021-05-20
• Device Publish Date: 2021-05-12

On-Brand Devices [Constrictor® Mini Button Extender]

• 00854629006765: Mini Extended Button to be used with Constrictor® Mini (Non-Sterile)
• 00854629006758: Mini Extended Button to be used with Constrictor® Mini (AB-3000)