MESH DWA-19-13

GUDID B772DWA1913

PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE

MEDYGLOBAL MEDICAL DEVICES SL.

Polydioxanone/polyethylene suture

• Primary Device ID: B772DWA1913
• NIH Device Record Key: b8701ad6-c25f-412a-bd3e-8802a330db0e
• Commercial Distribution Discontinuation: 2024-06-24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MESH
• Version Model Number: 8X1
• Catalog Number: DWA-19-13
• Company DUNS: 465769007
• Company Name: MEDYGLOBAL MEDICAL DEVICES SL.
• Device Count: 8
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B772DWA1913 [Primary]
HIBCC	MESHDWA1913 [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: 2021-06-15
• Device Publish Date: 2021-06-07

On-Brand Devices [MESH]

• B772DWA1913: PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE
• B772DWA1912: PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE