FDA UDI
In Commercial Distribution
🇺🇸 United States
PREMIXSLIP (4.2oz/125ml with mister)
DI: 00810929010352
·
Model: 34552-09
·
Ruhof Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PREMIXSLIP (4.2oz/125ml with mister)
- Primary DI
- 00810929010352
- Version / Model
- 34552-09
- Company Name
- Ruhof Corporation
- Labeler DUNS
- 082779828
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-24
- Public Version
- 1
- Public Version Date
- 2025-07-02
- Public Version Status
- New
- Public Device Record Key
- 3fa47c03-549e-4e07-a63e-a9167b0f2fe1
Device Description
Lubricant for medical Instrument
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | General Hospital | 880.6150 | 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 |
|---|---|---|---|---|---|---|
| Package | 00810929010369 | GS1 | CASE | 100 | In Commercial Distribution | |
| Primary | 00810929010352 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 40 – 130 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 130 Degrees Fahrenheit