FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDOZIME ULTIMATE (4 Liter FB63)
DI: 00810929042636
·
Model: 34599-33
·
Ruhof Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ENDOZIME ULTIMATE (4 Liter FB63)
- Primary DI
- 00810929042636
- Version / Model
- 34599-33
- Company Name
- Ruhof Corporation
- Labeler DUNS
- 082779828
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-02
- Public Version
- 1
- Public Version Date
- 2025-07-10
- Public Version Status
- New
- Public Device Record Key
- 5795a35b-0d9d-4692-9d37-a6b3239b482b
Device Description
Enzymatic detergents used to clean medical instruments.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | General Hospital | 880.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63385 | Medical device cleaning agent | A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. 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 | 10810929042633 | GS1 | case | 4 | In Commercial Distribution | |
| Primary | 00810929042636 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 40 – 130 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 130 Degrees Fahrenheit