FDA UDI
In Commercial Distribution
🇺🇸 United States
ECOtip HVE Tips Polka Dot
DI: 00723896010747
·
Model: 10410006
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- ECOtip HVE Tips Polka Dot
- Primary DI
- 00723896010747
- Version / Model
- 10410006
- Catalog Number
- 71-08313
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-07-19
- Public Version
- 1
- Public Version Date
- 2018-08-20
- Public Version Status
- New
- Public Device Record Key
- 4e7bc362-2c6f-4abe-9929-b475d6f4f651
Device Description
Made from renewable, sustainable paper, ECOtip Earth-Friendly High Volume Evacuator Tips are the high-performance alternative to plastics. ECOtip is engineered and tested to provide outstanding stiffness, durability, and function. Food-grade coating eliminates moisture absorption and fraying during use. Tips fit standard HVE valves. Made under strict ISO standards from FDA-approved materials.
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 | 00723896010754 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00723896010747 | GS1 | ||||
| Unit of Use | 00723896002902 | GS1 |