Identity
- Trade Name
- Biofill Infiltration Cannula FDA UDI
- Generic Name
- Liposuction system cannula, single-use FDA UDI
- Device Name
- Biofill Infiltration Cannula, Ø=2.5mm, L=15cm, 0 Holes, Single-use, Infiltration FDA UDI
- Model / Reference
- Single-use, Ø=2.5, L=150, 0H, Infiltration FDA UDI
- Description
- Biofill Infiltration Cannula, Ø=2.5mm, L=15cm, 0 Holes, Single-use, Infiltration FDA UDI
Identifiers
- Catalog Number
- 1580107-5 FDA UDI
- Primary DI / UDI-DI
- 04260170881021 FDA UDI
- 510(k) Number
- K082025 FDA UDI
- FDA Product Code
- QPB FDA UDI
- GMDN Term
- Liposuction system cannula, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Liposuction system cannula, single-use
Biofill Infiltration Cannula by Human Med AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Liposuction system cannula, single-use.
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- SUMMIT MEDICAL — Summit Medical, LLC · Class I
- Multi Rapid Extraction Cannula — Möller Medical GmbH · Class I
Cleared under the same submission
K082025 also covers:
- Biofill Cannula — Human Med AG
- Biofill Cannula — Human Med AG
- Biofill Cannula — Human Med AG
- Biofill applicator — Human Med AG
- Biofill cannula — Human Med AG
- Biofill cannula — Human Med AG
- Biofill cannula — Human Med AG
- Biofill cannula, RAPID — Human Med AG
- Biofill infiltration cannula — Human Med AG
- Hydrophobic Filter-set — Human Med AG
- Hydrophobic Filter-set — Human Med AG
- Hydrophobic Filter-set — Human Med AG
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
- Human Med AG
Sources (1)
- FDA UDI 6c21380c-4192-4b94-be41-eaf52eb70481 37 fields · synced Jun 8, 2026