Identity
- Trade Name
- DIOnavi-SG02 FDA UDI
- Generic Name
- Hand-held dental retractor FDA UDI
- Model / Reference
- 3DCLRSG-1000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169099495 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Hand-held dental retractor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand-held dental retractor
DIOnavi-SG02 by DIO Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held dental retractor.
- Power Dental USA — Power Dental USA, Inc. · Class I
- Tatum Sinus Retractor — SUNCOAST DENTAL, INC. · Class I
- devemed — devemed GmbH · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- STOMA® — Storz am Mark GmbH · Class I
- EXPANDER — KLS-Martin L.P. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- DIO Corporation
Sources (1)
- FDA UDI 09873dd5-9791-4da1-8b22-910ea2be26b1 32 fields · synced Jun 8, 2026