Identity
- Trade Name
- Faset FDA UDI
- Generic Name
- Laparoscopic access cannula dilator FDA UDI
- Device Name
- Dilator Large FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Dilator Large FDA UDI
Identifiers
- Catalog Number
- FA.IN.3001 FDA UDI
- Primary DI / UDI-DI
- 08800039820318 FDA UDI
- 510(k) Number
- K180729 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- Laparoscopic access cannula dilator FDA UDI
Classification
- Device Class
- U 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Laparoscopic access cannula dilator
Faset by Dio Medical Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic access cannula dilator.
- VersaStep — Covidien LP · Class II
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- ZESPIN SI Joint Fusion System — Aegis Spine, Inc. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- METRx® System — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- TUBULAR Access — CTL Medical Corporation · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Cleared under the same submission
K180729 also covers:
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI 115fa576-0719-4436-8cba-f3ecc95867ed 36 fields · synced May 30, 2026