Identity
- Trade Name
- Keller Funnel 2 EUDAMEDFDA UDI
- Generic Name
- Breast implant delivery sleeve FDA UDI
- Device Name
- KELLER FUNNEL EUDAMEDSilicone Breast Implant Insertion Device FDA UDI
- Model / Reference
- HA-001 EUDAMEDFDA UDI
- Description
- Silicone Breast Implant Insertion Device FDA UDI
Identifiers
- Catalog Number
- HA-001 FDA UDI
- Primary DI / UDI-DI
- 10888628043732 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840228300064M EUDAMEDB-10888628043732 EUDAMED
- FDA Product Code
- KDD FDA UDI
- EMDN Code
- P0680 BREAST IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Breast implant delivery sleeve FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Keller Funnel 2 by Allergan Sales, LLC — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0840228300064M | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0840228300064M | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Allergan Sales, LLC
- EUDAMED SRN
- US-MF-000001517
- Authorised Representative
- Quality First International OÜ EE-AR-000004308
Sources (3)
- EUDAMED df044c37-2318-4825-a897-849589986bfe 61 fields · synced Jul 25, 2026
- EUDAMED 4ef71b25-a39a-413c-9950-f0da4d4a3cd4 61 fields · synced May 19, 2026
- FDA UDI 291e94d9-bce1-46fe-9291-84d0200878e4 35 fields · synced May 30, 2026