FDA UDI
In Commercial Distribution
🇺🇸 United States
Flip-SE
DI: 00814005022840
·
Model: Flip-SE
·
Quality Aspirators, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Flip-SE
- Primary DI
- 00814005022840
- Version / Model
- Flip-SE
- Catalog Number
- 311-10001
- Company Name
- Quality Aspirators, Inc.
- Labeler DUNS
- 121431159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-27
- Public Version
- 1
- Public Version Date
- 2025-03-07
- Public Version Status
- New
- Public Device Record Key
- ecc81b75-85e4-4093-817f-7e7b75473a2a
Device Description
Flip-SE
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EHZ | Evacuator, oral cavity | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63828 | Dental suction system activation valve | An electrically-powered device intended to be permanently integrated within a dental suction system, between the pump and the suction handpiece, to open (activate) and close the suction line between uses. It includes an electronic switching mechanism which allows the valve to be opened using the vacuum generated by the pump. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814005022840 | GS1 |