Identity
- Trade Name
- TEMPO FDA UDI
- Generic Name
- Angiographic catheter, single-use FDA UDI
- Device Name
- 5 F TEMPO 0.038 INCHES 80CM MS20 FDA UDI
- Model / Reference
- SRD6573 FDA UDI
- Description
- 5 F TEMPO 0.038 INCHES 80CM MS20 FDA UDI
Identifiers
- Catalog Number
- SRD6573 FDA UDI
- Primary DI / UDI-DI
- 10705032050159 FDA UDI
- 510(k) Number
- K181836 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Angiographic catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
Category: Angiographic catheter, single-use
Tempo by Cordis Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- INFINITI — Cordis US Corp. · Class II
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Cleared under the same submission
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
- Cordis Corp.
Sources (1)
- FDA UDI 6fc6ea4e-e31e-49e2-b028-b10884885d19 35 fields · synced Jun 1, 2026