FDA UDI
In Commercial Distribution
🇺🇸 United States
Mirro-Vac Saliva Ejector Mirrors
DI: 00723896010006
·
Model: 70-42615
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Mirro-Vac Saliva Ejector Mirrors
- Primary DI
- 00723896010006
- Version / Model
- 70-42615
- Catalog Number
- 70-42615
- 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
- 2
- Public Version Date
- 2018-12-21
- Public Version Status
- Update
- Public Device Record Key
- 4119a83a-8d47-4d58-8545-f1bb0c764bab
Device Description
Reduce number of hands needed, instruments used and procedure time! The Mirro-Vac Saliva Ejector Mirror combines evacuator and mirror functions into one efficient instrument. Ideal for sealants, air abrasion, bonding and other dry field procedures. Upper suction inlet relieves tissue grab and ensures anti-fog acrylic mirror stays clear-even under direct exhalation. Size 4 lens with 35 degree inclination delivers standard mouth mirror feel and function without compromise. Easy-lift film protects mirror surface until use.Soft blue color eases patient anxiety.Round, knurled handle improves grip.Fully disposable, one-piece construction eliminates need for sterilization. 6" long. 50 mirrors 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 |
|---|---|---|---|---|
| 31776 | Dental mirror, reusable | A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896010013 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00723896010006 | GS1 | ||||
| Unit of Use | 00723896001820 | GS1 |