Identity
- Trade Name
- TISSU-TRANS FILTRON EUDAMEDSUMMIT MEDICAL FDA UDI
- Generic Name
- Autologous adipose tissue reinjection set FDA UDI
- Device Name
- TISSU-TRANS FILTRON 2000 CC EUDAMED
- Model / Reference
- 3-TT-FILTRON 2000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00385640053785 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00385640053785 EUDAMED
- 510(k) Number
- K092482 FDA UDI
- FDA Product Code
- MUU FDA UDI
- EMDN Code
- A06030401 INTRAOPERATIVE SUCTION CONTAINERS EUDAMED
- GMDN Term
- Autologous adipose tissue reinjection set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5040 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Autologous adipose tissue reinjection set
Summit Medical by Summit Medical, LLC — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Autologous adipose tissue reinjection set.
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- Adinizer — Bsl Co. · Class II
- Adinizer — Bsl Co. · Class II
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- Adinizer — Bsl Co. · Class II
- Adinizer — Bsl Co. · Class II
Cleared under the same submission
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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Summit Medical, LLC
Sources (2)
- FDA UDI bd27dd43-5bf5-4170-aa9b-c99316570616 33 fields · synced Jul 31, 2026
- EUDAMED 1b8bd29b-4577-464b-89e6-872e64ab32d7 61 fields · synced Jul 31, 2026