Identity
- Trade Name
- JETSTREAM XC FDA UDI
- Generic Name
- Atherectomy/thrombectomy rotational catheter FDA UDI
- Device Name
- JETSTREAM XC 2.1 MM, FG PKG FDA UDI
- Model / Reference
- 112264-001 FDA UDI
- Description
- JETSTREAM XC 2.1 MM, FG PKG FDA UDI
Identifiers
- Catalog Number
- 112264 FDA UDI
- Primary DI / UDI-DI
- 00616258005140 FDA UDI
- FDA Product Code
- MCW FDA UDI
- GMDN Term
- Atherectomy/thrombectomy rotational catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 7 French FDA UDI
Category: Atherectomy/thrombectomy rotational catheter
Jetstream Xc by Bayer Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Atherectomy/thrombectomy rotational catheter.
- JETSTREAM XC — Bayer Healthcare · Class II
- JETSTREAM SC — Bayer Healthcare · Class II
- JETSTREAM SC — Bayer Healthcare · 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
- Bayer Healthcare
Sources (1)
- FDA UDI d5680906-d149-4b32-bf8b-f41a2a1ab4e7 36 fields · synced May 31, 2026