Identity
- Trade Name
- SUMMIT MEDICAL FDA UDI
- Generic Name
- Liposuction system FDA UDI
- Model / Reference
- FL3000M-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00385640061445 FDA UDI
- FDA Product Code
- MUU FDA UDI
- GMDN Term
- Liposuction system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Liposuction system
Summit Medical by Summit Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092284 also covers:
K092482 also covers:
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
- SUMMIT MEDICAL — Summit Medical, LLC
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
- Summit Medical, LLC
Sources (1)
- FDA UDI 913e144b-854d-4a9e-89cf-e65f9dc81487 33 fields · synced May 30, 2026