Duns Number:080315253
Device Description: DuraStat is indicated for use in general soft tissue approximation and/or ligation, includ 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.
Catalog Number
-
Brand Name
DuraStat
Version/Model Number
GZL-002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173335
Product Code
NBY
Product Code Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Public Device Record Key
7edbb595-0377-480d-881e-fe430e250be2
Public Version Date
February 04, 2020
Public Version Number
3
DI Record Publish Date
March 25, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |