FDA UDI
In Commercial Distribution
🇺🇸 United States
OptiSonic™ super-concentrated general purpose ultrasonic cleaning solution
DI: D6870321362FG2
·
Model: 0321362FG
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- OptiSonic™ super-concentrated general purpose ultrasonic cleaning solution
- Primary DI
- D6870321362FG2
- Version / Model
- 0321362FG
- Catalog Number
- 0321362FG
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 6
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 2d094f5e-51b1-4d33-a411-cf7cb6d406bd
Device Description
OptiSonic™ super-concentrated general purpose ultrasonic cleaning solution, general purpose Six 16-oz Bettix Bottles
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 47631 | Medical device disinfection agent | A non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D6870321362FG2 | HIBCC | ||||
| Unit of Use | D6870321362FG0 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Six 16-oz Bettix Bottles | ||
| Total Volume | 16 | Fluid Ounce |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store below freezing.
- Type
- Storage Environment Temperature
- Temperature Range
- 65 – 85 Degrees Fahrenheit