Identity
- Trade Name
- Kosmos FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- MENDAERA 210-00160: PACKAGED LINEAR LEXSA PROBE FDA UDI
- Model / Reference
- P008041 FDA UDI
- Description
- MENDAERA 210-00160: PACKAGED LINEAR LEXSA PROBE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000847 FDA UDI
- 510(k) Number
- K212100 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI
- Commercial Distribution
- 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
MR Unsafe FDA UDI
Category: Extracorporeal ultrasound imaging transducer, hand-held
Kosmos by EchoNous — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Extracorporeal ultrasound imaging transducer, hand-held.
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- SonoScape — SONOSCAPE MEDICAL CORP. · Class II
- 4C1 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- UST-5419 — FUJIFILM Corporation · Class II
- P4-12 — SAMSUNG MEDISON CO., LTD · Class II
Cleared under the same submission
K212100 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EchoNous
Sources (1)
- FDA UDI 20827906-68de-4eb3-b86d-8a635b97c707 34 fields · synced May 30, 2026