FDA UDI
In Commercial Distribution
🇺🇸 United States
MK-dent
DI: E490LU10221
·
Model: PREMIUM SERVICE OIL
·
MK-Dent GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MK-dent
- Primary DI
- E490LU10221
- Version / Model
- PREMIUM SERVICE OIL
- Catalog Number
- LU1022
- Company Name
- MK-Dent GmbH
- Labeler DUNS
- 343618943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-14
- Public Version
- 1
- Public Version Date
- 2024-10-22
- Public Version Status
- New
- Public Device Record Key
- cd0314af-a2f9-46bb-bcd9-06b932597cbb
Device Description
Lubricant for maintenance
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15772 | Surgical instrument maintenance lubricant | A non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E490LU10221 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 122 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- – 122 Degrees Fahrenheit