FDA UDI
In Commercial Distribution
🇺🇸 United States
Ritewipe Dental Handpiece Cleaning Wipes
DI: 00860012058204
·
Model: Pouch - 100 Count 5"X7"
·
RITEWIPE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Ritewipe Dental Handpiece Cleaning Wipes
- Primary DI
- 00860012058204
- Version / Model
- Pouch - 100 Count 5"X7"
- Company Name
- RITEWIPE, LLC
- Labeler DUNS
- 125757592
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-09
- Public Version
- 1
- Public Version Date
- 2024-09-17
- Public Version Status
- New
- Public Device Record Key
- 5e93cb7f-d562-4c10-8a46-1ae01b518d0d
Device Description
Pouch - 100 Count 5"X7" Dental Handpiece Cleaning Wipes
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | General Hospital | 880.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58077 | Medical device cleaning/disinfection wipe | A moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012058204 | GS1 | ||||
| Package | 00860012058211 | GS1 | Carton | 12 | In Commercial Distribution | |
| Package | 00860012058273 | GS1 | Pallet | 21 | In Commercial Distribution | |
| Package | 00860012058280 | GS1 | Pallet | 42 | In Commercial Distribution | |
| Package | 00860012058297 | GS1 | Pallet | 84 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-877-947-3123
- [email protected]