Identity
- Trade Name
- INNOVA FDA UDI
- Generic Name
- Stationary angiographic x-ray system, digital FDA UDI
- Device Name
- INNOVA IGS 540 ACT 001 UDI FDA UDI
- Model / Reference
- IGS 540 ACT 001 FDA UDI
- Description
- INNOVA IGS 540 ACT 001 UDI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682120272 FDA UDI
- 510(k) Number
- K091673 FDA UDI
- FDA Product Code
- JAK FDA UDIJAA FDA UDIOWB FDA UDIIZI FDA UDI
- GMDN Term
- Stationary angiographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI892.1650 FDA UDI892.1600 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Innova by Hangwei GE Medical Systems Co., Ltd. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Hangwei GE Medical Systems Co., Ltd.
Sources (1)
- FDA UDI b24dfd8a-1ae4-4601-84b6-46d036099d78 35 fields · synced Jun 8, 2026