FDA UDI
In Commercial Distribution
🇺🇸 United States
DisposEvac All-in-One HVE Tips
DI: 00723896010105
·
Model: 70-42627
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- DisposEvac All-in-One HVE Tips
- Primary DI
- 00723896010105
- Version / Model
- 70-42627
- Catalog Number
- 70-42627
- 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
- c9da0cf7-5518-44c1-ad78-1246ca5a66f3
Device Description
Replace your heavy, bulky metal HVE valves with DisposEvac All-in-One HVE Tips and eliminate the hassle and expense of maintenance and sterilization. Simply replace your existing adapter with the DisposEvac Hose Adapter and use 100% disposable DisposEvac tips to eliminate cross-contamination. Ergonomic, built-in valve opens and closes with an easy sliding action. Lightweight plastic construction reduces fatigue during long procedures. Tips may be rotated for extra convenience. Requires simple, one-time installation of hose adapter. Vented green tip. 8" long overall. 50 per bag.
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 | 00723896010112 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00723896010105 | GS1 | ||||
| Unit of Use | 00723896008713 | GS1 |