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 Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer 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