Identity
- Trade Name
- Faset FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- Awl, Cannulated FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Awl, Cannulated FDA UDI
Identifiers
- Catalog Number
- FA.IC.1001 FDA UDI
- Primary DI / UDI-DI
- 08800039825290 FDA UDI
- 510(k) Number
- K180729 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- Bone awl, reusable 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: Bone awl, reusable
Faset by Dio Medical Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone awl, reusable.
- Vital™ MIS Spinal Fixation System — BIOMET SPINE LLC · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- Navigated Instruments — EVOLUTION SPINE, LLC · Class II
- PYRENEES Cervical Plate System — K2M, INC. · Class I
- Awl — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- CONMED — Conmed Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Medtronic Reusable 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 5b7bdc5c-f811-45bb-a709-e881911648dc 36 fields · synced May 31, 2026