FDA UDI
In Commercial Distribution
🇺🇸 United States
INSTRUSLIP (4 Liter RB38)
DI: 00810929042063
·
Model: 34574-29
·
Ruhof Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- INSTRUSLIP (4 Liter RB38)
- Primary DI
- 00810929042063
- Version / Model
- 34574-29
- Company Name
- Ruhof Corporation
- Labeler DUNS
- 082779828
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-30
- Public Version
- 1
- Public Version Date
- 2025-07-08
- Public Version Status
- New
- Public Device Record Key
- 660667f0-171a-4182-bf29-381b67bfc8c6
Device Description
Enzymatic detergents used to clean medical instruments.
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
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 58062 | Instrument anti-oxidation agent | A liquid substance intended to prevent corrosion on the surface of stainless steel medical/surgical instruments (e.g., specula, forceps) through its anti-oxidation properties. It is typically a concentrated phosphoric acid (H3PO4) that is used as specified by the manufacturer in an aqueous solution to treat devices by manual soaking or in an ultrasonic water bath. Also known as an instrument renovating agent, it is intended to remove protein stains, iron oxide deposits, and other oxide stains to prevent rust pitting and help improve instrument longevity. 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 | 10810929042060 | GS1 | CASE | 4 | In Commercial Distribution | |
| Primary | 00810929042063 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 40 – 130 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 130 Degrees Fahrenheit