Identity
- Trade Name
- TissueStat FDA UDI
- Generic Name
- Suturing needle holder, single-use FDA UDI
- Device Name
- TissueStat (TIS-003) is a class I suture deployment device that allows healthcare professionals to place a needle through soft tissue and facilitates the placement of sutures and knot tying for tissue approximation and/or ligation. FDA UDI
- Model / Reference
- TIS-003 FDA UDI
- Description
- TissueStat (TIS-003) is a class I suture deployment device that allows healthcare professionals to place a needle through soft tissue and facilitates the placement of sutures and knot tying for tissue approximation and/or ligation. FDA UDI
Identifiers
- Catalog Number
- TIS-003 FDA UDI
- Primary DI / UDI-DI
- B532TIS0030 FDA UDI
- FDA Product Code
- HXK FDA UDI
- GMDN Term
- Suturing needle holder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
TissueStat by DuraStat — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- DuraStat
Sources (1)
- FDA UDI 0e0d9c8b-9c0a-4986-9d29-fa1a0fc2403a 36 fields · synced May 29, 2026