Force DFX Suture DFX-5-36-S-WBL-48

GUDID 00854629006505

Force DFX Suture™ #5 (UHMWPE) 36" HS48 1/2 Circle Reverse Cutting Needle - 48mm

DUNAMIS MEDICAL, LLC

Polyolefin suture, multifilament

• Primary Device ID: 00854629006505
• NIH Device Record Key: 842ff904-a54a-4477-a2b6-287fe27a1995
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Force DFX Suture
• Version Model Number: DFX-5-36-S-WBL-48
• Catalog Number: DFX-5-36-S-WBL-48
• 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	00854629006499 [Primary]
GS1	00854629006505 [Package]; Contains: 00854629006499; Package: Box [12 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-01-12

On-Brand Devices [Force DFX Suture]

• 00854629006505: Force DFX Suture™ #5 (UHMWPE) 36" HS48 1/2 Circle Reverse Cutting Needle - 48mm
• 10854629006489: Force DFX Suture™ #2 (UHMWPE) 36" HC-5 1/2 Circle Taper Point Needle - 25.9mm