BOX DWFB-18-03

GUDID B772DWFB1803

PDO TRHREADS BIOABSORBABLE MATERIAL WITH NEEDLE

MEDYGLOBAL MEDICAL DEVICES SL.

Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Polydioxanone/polyethylene suture Composite-polymer suture Composite-polymer suture Composite-polymer suture Composite-polymer suture Composite-polymer suture Composite-polymer suture Composite-polymer suture Composite-polymer suture Composite-polymer suture Composite-polymer suture Composite-polymer suture Composite-polymer suture

• Primary Device ID: B772DWFB1803
• NIH Device Record Key: 77385351-f726-47b2-ac3f-558e87bb209c
• Commercial Distribution Discontinuation: 2024-06-24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOX
• Version Model Number: 20X1
• Catalog Number: DWFB-18-03
• Company DUNS: 465769007
• Company Name: MEDYGLOBAL MEDICAL DEVICES SL.
• Device Count: 20
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B772DWFB1803 [Primary]
HIBCC	BOXDWFB1803 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160761

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

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: 2021-06-14
• Device Publish Date: 2021-06-04

Devices Manufactured by MEDYGLOBAL MEDICAL DEVICES SL.

• B772DWA1912 - MESH: 2021-06-15 PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE
• B772DWA1913 - MESH: 2021-06-15 PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE
• B772DWB1903 - SUPERTORNADO: 2021-06-15 PDO THREADS WITH BIOABSORBALE MATERIAL WITH NEEDLE
• B772DWB2101 - SCREWCOG: 2021-06-15 PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE
• B772DWCB1912 - RHINO: 2021-06-15 PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE
• B772DWCB1913 - RHINO: 2021-06-15 PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE
• B772DWFB1801 - HARPOON: 2021-06-15 PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE
• B772DWFB1802 - HARPOON: 2021-06-15 PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE