Syndesmosis Repair Implantation System AB-2250

GUDID 00854629006703

Syndesmosis Repair Implantation System

DUNAMIS MEDICAL, LLC

Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use

• Primary Device ID: 00854629006703
• NIH Device Record Key: 0431ff5f-2bf9-41e3-8e3d-35495a9b737b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syndesmosis Repair Implantation System
• Version Model Number: AB-2250
• Catalog Number: AB-2250
• Company DUNS: 079471560
• Company Name: DUNAMIS MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00854629006703 [Primary]

FDA Product Code

• HTW: Bit, Drill

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: 2021-04-30
• Device Publish Date: 2021-04-22

On-Brand Devices [Syndesmosis Repair Implantation System]

• 00854629006703: Syndesmosis Repair Implantation System
• 00854629006741: Syndesmosis Repair Implantation System For use with AB-3000
• 10854629006861: 3.3mm Syndesmosis Repair Implantation System For use with AB-3000