HARPOON DWFB-18-02

GUDID B772DWFB1802

PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE

MEDYGLOBAL MEDICAL DEVICES SL.

Polydioxanone/polyethylene suture

• Primary Device ID: B772DWFB1802
• NIH Device Record Key: 14797326-b400-43c2-bb72-6a4bba38f849
• Commercial Distribution Discontinuation: 2024-06-24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARPOON
• Version Model Number: 20X1
• Catalog Number: DWFB-18-02
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B772DWFB1802 [Primary]
HIBCC	HARPOONDWFB1802 [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 [HARPOON]

• B772DWFB1902: PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE
• B772DWFB1901: PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE
• B772DWFB1802: PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE
• B772DWFB1801: PDO THREADS BIOABSORBABLE MATERIAL WITH NEEDLE