FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040027820
·
Model: 5702110
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040027820
- Version / Model
- 5702110
- Catalog Number
- 5702110
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2020-08-24
- Public Version
- 1
- Public Version Date
- 2020-09-01
- Public Version Status
- New
- Public Device Record Key
- 3fbbc89e-ebcf-4009-8f95-594cddeee293
Device Description
Caries Indicator Syringe Red
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LFC | DEVICE, CARIES DETECTION | Dental | 872.1740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33995 | Dental caries detector, optical induced fluorescence | A mains electricity (AC-powered) device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries. It consists of a light source (typically a laser) that elicits fluorescence in teeth, and a unit that quantifies the altered fluorescence of the carious tooth tissue. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20304040027824 | GS1 | case | 30 | In Commercial Distribution | |
| Primary | 00304040027820 | GS1 | ||||
| Unit of Use | 10304040027827 | GS1 |