Identity
- Trade Name
- Hana ACP FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Drill bit, 18mm FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Drill bit, 18mm FDA UDI
Identifiers
- Catalog Number
- UP.IN.0013 FDA UDI
- Primary DI / UDI-DI
- 08800039800839 FDA UDI
- 510(k) Number
- K173099 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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: Fluted surgical drill bit, reusable
Hana ACP by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, reusable.
- RingLoc® + — Biomet Orthopedics, Inc. · Class I
- DLC Cortical Bone Drill 5.7mmD Implant — IMPLANT DIRECT SYBRON MANUFACTURING LLC · Class II
- MatrixMANDIBLE — Synthes · Class II
- Brasseler — SUNCOAST DENTAL, INC. · Class I
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
- Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
- Straight Twist Drill — DENTIS CO. , LTD · Class I
Cleared under the same submission
K173099 also covers:
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI b9a1d143-1eeb-4b86-8916-d7366be3c1e1 36 fields · synced May 30, 2026