FDA UDI
In Commercial Distribution
🇺🇸 United States
OSUNG MND
DI: 08800075604187
·
Model: MPM
·
OSUNG MND Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OSUNG MND
- Primary DI
- 08800075604187
- Version / Model
- MPM
- Company Name
- OSUNG MND Co., Ltd.
- Labeler DUNS
- 688207479
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-19
- Public Version
- 1
- Public Version Date
- 2024-02-27
- Public Version Status
- New
- Public Device Record Key
- bee3b4a7-16a6-4a74-a09f-eed08ded54aa
Device Description
A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. This is a reusable device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BRW | Protector, Dental | Anesthesiology | 868.5820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16197 | Mouth gag, non-adjustable | A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800075604187 | GS1 |