Identity
- Trade Name
- Tenzing 7 Delivery Catheter FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Device Name
- Tenzing 7 Delivery Catheter; Contains Tenzing 7 Delivery Catheter (00853799007541) FDA UDI
- Model / Reference
- Gen 1 FDA UDI
- Description
- Tenzing 7 Delivery Catheter; Contains Tenzing 7 Delivery Catheter (00853799007541) FDA UDI
Identifiers
- Catalog Number
- REF 1005 FDA UDI
- Primary DI / UDI-DI
- 00853799007534 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Vascular microcatheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
Yes
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
Tenzing 7 Delivery Catheter by Route 92 Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Route 92 Medical, Inc.
Sources (2)
- FDA UDI dc0ffe46-17a1-46d0-b179-ebb9c16bfa1b 36 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 3, 2026