Identity
- Trade Name
- FOURTE Expander Fill System FDA UDI
- Generic Name
- Tissue expander injection port FDA UDI
- Device Name
- FOURTE Expander Fill System FDA UDI
- Model / Reference
- F-4444L FDA UDI
- Description
- FOURTE Expander Fill System FDA UDI
Identifiers
- Catalog Number
- F-4444L FDA UDI
- Primary DI / UDI-DI
- 10888628043602 FDA UDI
- 510(k) Number
- K161483 FDA UDI
- FDA Product Code
- LCJ FDA UDI
- GMDN Term
- Tissue expander injection port FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tissue expander injection port
FOURTE Expander Fill System by Allergan — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue expander injection port.
- Wall Expander (Side cutter) — DENTIS CO. , LTD · Class I
- B.BRAUN — B. BRAUN MEDICAL INC. · U
- B.BRAUN — B. BRAUN MEDICAL INC. · U
- B.BRAUN — B. BRAUN MEDICAL INC. · U
- SIENTRA Remote Injection Port — Sientra, Inc. · U
- B.BRAUN — B. BRAUN MEDICAL INC. · U
- B.BRAUN — B. BRAUN MEDICAL INC. · U
- SIENTRA Remote Injection Port — Sientra, Inc. · U
Cleared under the same submission
K161483 also covers:
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 U | Pending data |
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Manufacturer
- Manufacturer
- Allergan
Sources (1)
- FDA UDI 293cff88-a106-484c-9e7a-267a2ff4c02d 37 fields · synced May 30, 2026