Suture Passer - Single Loop DM-4890

GUDID 00850052601041

Suture Passer - Single Loop

DUNAMIS MEDICAL, LLC

Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire Orthopaedic bone wire

• Primary Device ID: 00850052601041
• NIH Device Record Key: 3feed46e-c245-4141-8190-b14c2472bb9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suture Passer - Single Loop
• Version Model Number: DM-4890
• Catalog Number: DM-4890
• 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

Customer Support Contacts

• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com
• Phone: 334-371-6280
• Email: info@dunamismedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850052601041 [Primary]

FDA Product Code

• HWQ: Passer

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: 2023-08-25
• Device Publish Date: 2023-08-17

Devices Manufactured by DUNAMIS MEDICAL, LLC

• 00850052601249 - Orca™ Implantation Kit: 2024-06-28 Orca™ Implantation Kit
• 00850052601072 - Hallux Guide: 2024-06-18 Hallux Guide
• 00850052601089 - CMC Spacer: 2024-06-18 CMC Spacer
• 00850052601096 - CMC Guide: 2024-06-18 CMC Guide
• 00850052601157 - Threaded Driver: 2024-06-18 Threaded Driver
• 00850052601232 - Micro Constrictor® Implantation Kit: 2024-06-18 Micro Constrictor® Implantation Kit
• 00850052601225 - Orca Xtreme ™ Kit Knotless Button: 2024-03-22 Orca Xtreme™ Kit Knotless Button
• 00850052601188 - Force DFX Suture-Xtreme™: 2024-02-08 Force DFX Suture-Xtreme™