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 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| customerservice@durastat.com | |
| Phone | 18008048018 |
| 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
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[B532GZL0020]
Ethylene Oxide
[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 |
Trademark Results [DuraStat]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURASTAT 88226184 not registered Live/Pending |
DURA TAP LLC 2018-12-12 |
 DURASTAT 85283394 4045366 Live/Registered |
Polymer Products Company, Inc. 2011-04-01 |
 DURASTAT 78519642 not registered Dead/Abandoned |
Durakon Industries, Inc. 2004-11-18 |
 DURASTAT 78354729 not registered Dead/Abandoned |
American Biltrite Inc. 2004-01-21 |
 DURASTAT 75517003 2294258 Dead/Cancelled |
Polymer Products Company, Inc. 1998-07-10 |
 DURASTAT 75416446 2232027 Dead/Cancelled |
Tennelec Nucleus Inc. 1998-01-12 |
 DURASTAT 74372313 1853118 Dead/Cancelled |
BURLINGTON INDUSTRIES, INC. 1993-03-26 |
 DURASTAT 74089243 1712652 Dead/Cancelled |
MENTOR OPHTHALMICS, INC. 1990-08-20 |
 DURASTAT 74038686 1676454 Dead/Cancelled |
PPG INDUSTRIES, INC. 1990-03-15 |
 DURASTAT 73176906 1124463 Dead/Cancelled |
THERADYNE CORPORATION 1978-07-03 |
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