Force DFX Suture Loop -Xtreme™ DFX0034S

GUDID 00850052601294

Force DFX Suture Loop-Xtreme™

DUNAMIS MEDICAL, LLC

Polyolefin/fluoropolymer suture, multifilament

• Primary Device ID: 00850052601294
• NIH Device Record Key: eb074376-3e21-42fa-b123-ced603bfdb61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Force DFX Suture Loop -Xtreme™
• Version Model Number: DFX34XSL
• Catalog Number: DFX0034S
• 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	00850052601294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150327

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2025-04-18
• Device Publish Date: 2025-04-10

Devices Manufactured by DUNAMIS MEDICAL, LLC

• 00850052601294 - Force DFX Suture Loop -Xtreme™: 2025-04-18Force DFX Suture Loop-Xtreme™
• 00850052601294 - Force DFX Suture Loop -Xtreme™: 2025-04-18 Force DFX Suture Loop-Xtreme™
• 00850052601256 - Micro Constrictor ®X Repair Kit: 2024-09-27 Micro Constrictor ® X Repair Kit
• 00850052601263 - Constrictor® Mini 2.0 Syndesmosis Repair Kit: 2024-09-27 Constrictor® Mini 2.0 Syndesmosis Repair Kit
• 00850052601270 - Constrictor® 2.0 Syndesmosis Repair Kit: 2024-09-27 Constrictor® 2.0Syndesmosis Repair Kit
• 00854629006789 - Constrictor® Mini Syndesmosis Repair Kit: 2024-09-27 Constrictor® Mini Syndesmosis Repair Kit
• 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