Identity
- Trade Name
- DuraStat FDA UDI
- Generic Name
- Suture kit, non-medicated FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- GZL-002 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B532GZL0020 FDA UDI
- 510(k) Number
- K173335 FDA UDI
- FDA Product Code
- NBY FDA UDI
- GMDN Term
- Suture kit, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5035 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
MR Safe FDA UDI
Category: Suture kit, non-medicated
DuraStat by DuraStat — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DuraStat
Sources (1)
- FDA UDI 7edbb595-0377-480d-881e-fe430e250be2 35 fields · synced May 30, 2026