Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Hand-held dental retractor FDA UDI
- Device Name
- A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device. FDA UDI
- Model / Reference
- GRM1 FDA UDI
- Description
- A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075613066 FDA UDI
- FDA Product Code
- EIG FDA UDI
- GMDN Term
- Hand-held dental retractor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Hand-held dental retractor
Osung Mnd by Osung Mnd Co., Ltd. — 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
- DIOnavi. Scan Retractor Lower jaw — DIO Corporation · 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
- Osung Mnd Co., Ltd.
Sources (1)
- FDA UDI 426970cb-37b1-4534-be5d-9b6a3948d2a2 33 fields · synced Jun 6, 2026