DuraStat

GUDID B532GZL0020

DuraStat is indicated for use in general soft tissue approximation and/or ligation, including: cardiovascular, dental, general surgical procedures and repair of the dura mater. DuraStat PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. DuraStat is provided sterile as a single-use device.

DURASTAT LLC

Suture kit, non-medicated

• Primary Device ID: B532GZL0020
• NIH Device Record Key: 7edbb595-0377-480d-881e-fe430e250be2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraStat
• Version Model Number: GZL-002
• Company DUNS: 080315253
• Company Name: DURASTAT LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: 18008048018
• Email: customerservice@durastat.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B532GZL0020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173335

FDA Product Code

• NBY: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[B532GZL0020]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-04
• Device Publish Date: 2019-03-25

Devices Manufactured by DURASTAT LLC

• B532TIS0010 - TissueStat: 2024-02-13 TissueStat 2-0 PTFE Kit
• B532TIS0040 - TissueStat: 2024-02-13 TissueStat 0 PGLA Kit
• B532TIS0030 - TissueStat: 2023-09-26 The TissueStat Convenience Kit (TIS-003) is a class I suture deployment device that allows healthcare professionals to place a n
• B532GZL0020 - DuraStat: 2020-02-04DuraStat is indicated for use in general soft tissue approximation and/or ligation, including: cardiovascular, dental, general surgical procedures and repair of the dura mater. DuraStat PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. DuraStat is provided sterile as a single-use device.
• B532GZL0020 - DuraStat: 2020-02-04 DuraStat is indicated for use in general soft tissue approximation and/or ligation, including: cardiovascular, dental, general s