FDA UDI
In Commercial Distribution
🇺🇸 United States
Dentus Ortholux
DI: 05414904256015
·
Model: DENTUS ORTHOLUX 18x24
·
AGFA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- Dentus Ortholux
- Primary DI
- 05414904256015
- Version / Model
- DENTUS ORTHOLUX 18x24
- Catalog Number
- 39N7P
- Company Name
- AGFA
- Labeler DUNS
- 374444883
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-10-31
- Public Version
- 1
- Public Version Date
- 2022-11-08
- Public Version Status
- New
- Public Device Record Key
- 8e1ddc6c-5366-438a-9a6b-41afcbac3140
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IWZ | Film, radiographic | Radiology | 892.1840 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40977 | Dental x-ray film, screen | A screen x-ray film specifically sized and designed for use with dental x-ray systems. It is designed to be sensitive primarily to the wavelengths of light emitted from an image intensifying screen. This x-ray film is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05414904255131 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 05414904256015 | GS1 | ||||
| Unit of Use | 05414904255391 | GS1 |
Customer Contacts
- Phone
- +1(877)777-2432
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 24 | Centimeter | |
| Length | 18 | Centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry, Keep away from direct sunlight and ionizing radiation (max 90 nGy/h). Only open in darkroom.