FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040151744
·
Model: 5702561
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040151744
- Version / Model
- 5702561
- Catalog Number
- 5702561
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2021-03-16
- Public Version
- 1
- Public Version Date
- 2021-03-24
- Public Version Status
- New
- Public Device Record Key
- 524169c5-4844-4428-a3c3-76fa5c84e09e
Device Description
Simple, effective way of maintaining clean dental unit waterlines. Simply add one tablet to your units water bottle, each time it is refilled, for continuous treatment. Tasteless, odorless, and has no affect on bonding. EPA registered to provide less than or equal to 10 CFU/mL. One tablet treats 700750 mL.
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
- 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 |
|---|---|---|---|---|
| NRD | Unit, operative dental, accessories | Dental | 872.6640 | 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 | 20304040151741 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 10304040151744 | GS1 | ||||
| Unit of Use | 00304040151747 | GS1 |