FDA UDI
In Commercial Distribution
🇺🇸 United States
Angle-Ease Colorz Adjustable HVE Tips
DI: 00723896009949
·
Model: 70-42609
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Angle-Ease Colorz Adjustable HVE Tips
- Primary DI
- 00723896009949
- Version / Model
- 70-42609
- Catalog Number
- 70-42609
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2018-07-18
- Public Version
- 1
- Public Version Date
- 2018-08-20
- Public Version Status
- New
- Public Device Record Key
- 669cdd17-bd1e-4c98-9acd-9bcc24bc225d
Device Description
ture assorted neon color combinations that add fun to their patented function. Like the original Angle-Ease, the 12 locking angle positions allow them to meet every treatment and operator requirement. Reduce fatigue and ease wrist strain. Keep hands clear of the working field. Optimize suction hose path and efficiency. Rigid design provides full cheek retraction. Reversible for right- or left-side assisting. Tips fit all standard HVE valves. Single-use plastic construction in purple, green and orange color combinations
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
- No
- 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 |
|---|---|---|---|---|
| EHZ | Evacuator, Oral Cavity | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37434 | Dental suction system cannula, single-use | A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896009956 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00723896009949 | GS1 | ||||
| Unit of Use | 00723896001011 | GS1 |