Identity
- Trade Name
- Unity FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- SIJ K wire sharp threaded (2.4mm OD) FDA UDI
- Model / Reference
- A FDA UDI
- Description
- SIJ K wire sharp threaded (2.4mm OD) FDA UDI
Identifiers
- Catalog Number
- SI.IN.0001 FDA UDI
- Primary DI / UDI-DI
- 08800039823678 FDA UDI
- 510(k) Number
- K173201 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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: Orthopaedic bone wire
Unity by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone wire.
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Cleared under the same submission
K173201 also covers:
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Unity — Dio Medical Co., Ltd.
- Unity — Dio Medical Co., Ltd.
- Unity — 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 |
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Manufacturer
- Manufacturer
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI 9b7a2a2b-bbaf-4df3-bff4-77a9e7cc82ca 36 fields · synced May 30, 2026