Identity
- Trade Name
- Edge Mini-Dock FDA UDI
- Generic Name
- Noninvasive device battery charger FDA UDI
- Device Name
- DIAGNOSTIC ULTRASOUND ACCAESSORY FDA UDI
- Model / Reference
- P15078-43 FDA UDI
- Description
- DIAGNOSTIC ULTRASOUND ACCAESSORY FDA UDI
Identifiers
- Catalog Number
- P15078 FDA UDI
- Primary DI / UDI-DI
- 00841517110369 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- GMDN Term
- Noninvasive device battery charger FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 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
Category: Noninvasive device battery charger
Edge Mini-Dock by Fujifilm Sonosite, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K113156 also covers:
K133454 also covers:
- Battery — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
- SonoSite Edge — Fujifilm Sonosite, Inc.
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
- Fujifilm Sonosite, Inc.
Sources (1)
- FDA UDI 437a5f78-7886-4534-83cf-e1636735fba2 36 fields · synced Jun 6, 2026