FDA UDI
In Commercial Distribution
🇺🇸 United States
Purevac® HVE
DI: D003CD20061
·
Model: CD2006
·
Dentsply Professional
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- Purevac® HVE
- Primary DI
- D003CD20061
- Version / Model
- CD2006
- Catalog Number
- CD2006
- Company Name
- Dentsply Professional
- Labeler DUNS
- 144140845
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2022-12-03
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- 97323b6d-a0b2-4498-b13a-f86ff44cb86b
Device Description
Purevac® HVE Mirror Tips 6 FS Rhodium
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 38759 | Dental suction system cannula, reusable | 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 made of metal or plastic materials that can be sterilized. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D003CD20060 | HIBCC | ||||
| Primary | D003CD20061 | HIBCC |