Identity
- Trade Name
- DESTINATION FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- DESTINATION Renal Guiding Sheath FDA UDI
- Model / Reference
- RSR02 FDA UDI
- Description
- DESTINATION Renal Guiding Sheath FDA UDI
Identifiers
- Catalog Number
- RSR02 FDA UDI
- Primary DI / UDI-DI
- 00389701006178 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
Dimensions & Sizes
- Size
- Length — 45 Centimeter FDA UDICatheter Gauge — 6 French FDA UDI
Category: Vascular catheter introduction set, nonimplantableVascular guide-catheter, single-use
Destination by Terumo Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mach1™ — Boston Scientific · Class II
- SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
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
- Terumo Medical Corporation
Sources (1)
- FDA UDI be66615b-866b-451d-a407-f106fab32983 37 fields · synced Jun 8, 2026