Identity
- Trade Name
- Faset FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Screw driver FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Screw driver FDA UDI
Identifiers
- Catalog Number
- FA.IN.7001 FDA UDI
- Primary DI / UDI-DI
- 08800039821391 FDA UDI
- 510(k) Number
- K180729 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- Surgical screwdriver, 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: Surgical screwdriver, reusable
Faset by Dio Medical Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · 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 |
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Manufacturer
- Manufacturer
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI be3ab6ea-4a80-4308-b40c-2b77e0378666 36 fields · synced Jun 8, 2026