Identity
- Trade Name
- Unity FDA UDI
- Generic Name
- Laparoscopic access cannula dilator FDA UDI
- Device Name
- SIJ 6mm Dialator FDA UDI
- Model / Reference
- A FDA UDI
- Description
- SIJ 6mm Dialator FDA UDI
Identifiers
- Catalog Number
- SI.IN.0004 FDA UDI
- Primary DI / UDI-DI
- 08800039822244 FDA UDI
- 510(k) Number
- K173201 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Laparoscopic access cannula dilator 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: Laparoscopic access cannula dilator
Unity by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 7ffe591e-f20a-4d63-974f-c9808a4d9249 36 fields · synced Jun 1, 2026