FDA UDI
Not in Commercial Distribution
🇺🇸 United States
The Glider™ Dental Treatment Station
DI: 00850309007770
·
Model: 90-2148
·
ASI MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- The Glider™ Dental Treatment Station
- Primary DI
- 00850309007770
- Version / Model
- 90-2148
- Company Name
- ASI MEDICAL, INC.
- Labeler DUNS
- 808695159
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-22
- Public Version
- 1
- Public Version Date
- 2022-11-30
- Public Version Status
- New
- Public Device Record Key
- 77221126-8312-47ae-9831-c4c3eeff8494
- Distribution End Date
- 2022-11-22
Device Description
Integrated delivery system with up to two handpiece connections, dual air/water syringes and titanium saliva ejector and high-volume evacuator. Delivery system features programmable electro-mechanically adjusted height to allow for sit down to stand up procedures and Wilsonart solid surface worktop and heavy duty 3” casters. Storage includes two side rails for accessory brackets, saline bag hooks, and sharps containers. Includes back rail with two storage tubs.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EIA | Unit, Operative Dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60930 | Dental delivery system instrument unit, electric | A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850309007770 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110481 | 000 |