Identity
- Trade Name
- 18L5S SMALL ARRAY LINEAR TRANSDUCER FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- 18L5 SMALL LINEAR ARRAY TRANSDUCER FDA UDI
- Model / Reference
- 18L5S SMALL ARRAY LINEAR TRANSDUCER FDA UDI
- Description
- 18L5 SMALL LINEAR ARRAY TRANSDUCER FDA UDI
Identifiers
- Catalog Number
- 1750488 FDA UDI
- Primary DI / UDI-DI
- 60889971750488 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
No
FDA UDI
18l5s Small Array Linear Transducer by Carestream Health, Inc. — 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
- Carestream Health, Inc.
Sources (1)
- FDA UDI a401f318-590b-4c51-9d9b-58a315f39a91 35 fields · synced Jun 8, 2026