Gynex Lugols
- Primary DI
- 10348783015574
- Brand
- Gynex Lugols
- Company
- PREMIER DENTAL PRODUCTS COMPANY
- Model
- 9045066
- Device description
- Lugol's Strong Iodine Solution, Non-Sterile, Single-Patient-Use, 12 single application - 8mL vials, 12 rayon tipped applicators
- Published
- 2026-02-03
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
Code, Name table| Code | Name |
|---|
| IAM | Solution, Lugol'S |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| IAM | Solution, Lugol'S | Pathology | 1 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10348783015574 | Package | GS1 | 20 | In Commercial Distribution |
| 00348783015577 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
Source identifier, GTIN-14 normalized, UPC-A table| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10348783015574 | 10348783015574 | | |
| 00348783015577 | 00348783015577 | 348783015577 | 0348783015577 |
Regulatory Flags#
- DUNS number
- 014789663
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
Other Devices Sharing Product Codes#
Primary DI, Brand, Company table| Primary DI | Brand | Company | Product code | Published |
|---|
| 00348783015577 | Gynex Lugols | PREMIER DENTAL PRODUCTS COMPANY | IAM | 2026-02-03 |
| 00348783001242 | Lugols | PREMIER DENTAL PRODUCTS COMPANY | IAM | 2023-05-09 |