Suture Passer - Single Loop DM-4890

GUDID 00850052601041

Suture Passer - Single Loop

DUNAMIS MEDICAL, LLC

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• 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

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• 00850052601188 - Force DFX Suture-Xtreme™: 2024-02-08 Force DFX Suture-Xtreme™
• 00850052601195 - Fixation Button-Oblong: 2024-02-08 Fixation Button-Oblong
• 20854629006912 - Orca™ Mini Knotless Button: 2024-02-08 Orca™ Mini Knotless Button
• 30854629006919 - Orca™ XL Knotless Tendon Repair: 2024-02-08 Orca™ XL Knotless Tendon Repair
• 40854629006916 - Orca™ Xtreme Knotless Button: 2024-02-08 Orca™ Xtreme Knotless Button
• 00850052601041 - Suture Passer - Single Loop: 2023-08-25Suture Passer - Single Loop
• 00850052601041 - Suture Passer - Single Loop: 2023-08-25 Suture Passer - Single Loop
• 00854629006321 - 5.5mm PunchTac™ Threaded Anchor PEEK: 2023-08-25 5.5mm PunchTac™ Threaded Anchor PEEK Preloaded with Two 2mm Fiber Connect (UHMWPE)