FDA UDI
In Commercial Distribution
🇺🇸 United States
Vibrant Disposable Mouth Mirrors
DI: 00723896019702
·
Model: 7158214
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
300
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Basic Information
- Brand Name
- Vibrant Disposable Mouth Mirrors
- Primary DI
- 00723896019702
- Version / Model
- 7158214
- Catalog Number
- 7158214
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 300
- Record Status
- Published
- Publish Date
- 2021-07-23
- Public Version
- 1
- Public Version Date
- 2021-08-02
- Public Version Status
- New
- Public Device Record Key
- 7b67955f-66d4-4abe-ba7e-6fa65825901a
Device Description
Pre-sterilized, single-use dental mouth mirrors
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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EAX | Mirror, Mouth | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64029 | Dental mirror, single-use | A sterile, 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00723896019719 | GS1 | CASE | 6 | In Commercial Distribution | |
| Primary | 00723896019702 | GS1 | ||||
| Unit of Use | 00723896019696 | GS1 |