FDA UDI
In Commercial Distribution
🇺🇸 United States
VacGuard HVE Tip Screens
DI: 00723896010082
·
Model: 1605-P01
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- VacGuard HVE Tip Screens
- Primary DI
- 00723896010082
- Version / Model
- 1605-P01
- Catalog Number
- 70-42626
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- 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
- b0f16d72-c052-4fc7-be44-f345f7746882
Device Description
reduce painful tissue plugs and prevent object aspiration as well. Ideal for softening the end of metal HVE tips. Extended design stays in place securely without blocking tip vent. Screens fit all standard 7⁄16" diameter HVE tips. 100 disposable blue plastic screens 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 | 00723896010099 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 00723896010082 | GS1 | ||||
| Unit of Use | 00723896005262 | GS1 |