Identity
- Trade Name
- RTI FDA UDI
- Generic Name
- Vascular dilator, reusable FDA UDI
- Device Name
- CLARITY DILATOR #4, 22MM FDA UDI
- Model / Reference
- 19-DILATOR-22 FDA UDI
- Description
- CLARITY DILATOR #4, 22MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059119534 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Vascular dilator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Rti by Tedan Surgical Innovations, L.l.c. — 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
- Tedan Surgical Innovations, L.l.c.
Sources (1)
- FDA UDI 3049cb23-9bff-4bf3-b744-e2aa8934a3e7 34 fields · synced Jun 1, 2026