FDA UDI
In Commercial Distribution
🇺🇸 United States
STERI-SOL® SYSTEM
DI: 00854542008044
·
Model: (01)00854542008044(21)101920213030
·
Anodia Systems
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STERI-SOL® SYSTEM
- Primary DI
- 00854542008044
- Version / Model
- (01)00854542008044(21)101920213030
- Catalog Number
- ITEM #: MAK-STERI
- Company Name
- Anodia Systems
- Labeler DUNS
- 030080456
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-18
- Public Version
- 1
- Public Version Date
- 2023-07-26
- Public Version Status
- New
- Public Device Record Key
- 855b31b5-86b2-44d0-8c25-0e04e5be5dbf
Device Description
Cutting/Cooling Fluid Delivery System for Dental High-Speed Handpiece Drills that Dispenses a cooling/cutting fluid, Steri-Sol® Solution during Dental Operative Procedures.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34991 | Dental delivery system | A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854542008044 | GS1 |
Customer Contacts
- Phone
- 866-246-2548
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K882491 | 000 |