FDA UDI
In Commercial Distribution
🇺🇸 United States
ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE)
DI: 00810929010147
·
Model: 345ESS4F
·
Ruhof Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE)
- Primary DI
- 00810929010147
- Version / Model
- 345ESS4F
- Company Name
- Ruhof Corporation
- Labeler DUNS
- 082779828
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-11
- Public Version
- 1
- Public Version Date
- 2025-07-21
- Public Version Status
- New
- Public Device Record Key
- 10af3b0f-c05d-4624-b58d-063757060cb4
Device Description
brushes to clean medical instrumnets
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
- 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 |
|---|---|---|---|---|
| 38335 | Semiconductor-type radiation survey meter | A portable or permanently installed radiation detection and spectroscopy instrument, that detects neutron, beta and alpha particles by the production of electron-hole pairs along the path of the charged particle in a semiconductor. It typically consists of a semiconductor diode, using an ohmic contact (a non rectifying electrode) and a detection circuit to measure the resulting current, electronics, and read out sub-system. The semiconductor acts like a solid ionization chamber. It has fast timing characteristics but is susceptible to performance degradation from radiation induced damage and may measure doses during radiation therapy treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810929011410 | GS1 | case | 100 | In Commercial Distribution | |
| Primary | 00810929010147 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 40 – 130 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 130 Degrees Fahrenheit