Identity
- Trade Name
- OSUNG MND FDA UDI
- Generic Name
- Dental anaesthesia syringe, reusable FDA UDI
- Device Name
- A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device. FDA UDI
- Model / Reference
- SAA1 FDA UDI
- Description
- A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800075614360 FDA UDI
- FDA Product Code
- EJI FDA UDI
- GMDN Term
- Dental anaesthesia syringe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6770 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: Dental anaesthesia syringe, reusable
Osung Mnd by Osung Mnd Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental anaesthesia syringe, reusable.
- Septodont — A.Titan Instruments · Class II
- BENCO — BENCO DENTAL SUPPLY CO. · Class II
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
- A. Titan Instruments — A.Titan Instruments · Class II
- Dentapen Protective Sleeve — JUVAPLUS SA · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Dentapen Injector — JUVAPLUS SA · Class II
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Osung Mnd Co., Ltd.
Sources (1)
- FDA UDI afdc97af-0986-4397-a1fc-3aceab47bbda 33 fields · synced Jun 8, 2026