Identity
- Trade Name
- Target Endoscopic Instrument FDA UDI
- Generic Name
- Endoscopic-access dilator, reusable FDA UDI
- Device Name
- [Target] TSD0001 Serial Dilator Set (TSD0001-1, TSD0001-2, TSD0001-3) FDA UDI
- Model / Reference
- TSD0001 FDA UDI
- Description
- [Target] TSD0001 Serial Dilator Set (TSD0001-1, TSD0001-2, TSD0001-3) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800147701226 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Endoscopic-access dilator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic-access dilator, reusable
Target Endoscopic Instrument by SOLENDOS Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- SOLENDOS Inc.
Sources (1)
- FDA UDI d44b93d3-9cf4-4202-8b78-60c9bfbc2ea0 34 fields · synced May 30, 2026