FDA UDI
In Commercial Distribution
🇺🇸 United States
Intraskan DC Plus
DI: 08904269400446
·
Model: 303-000134-24
·
SKANRAY TECHNOLOGIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Intraskan DC Plus
- Primary DI
- 08904269400446
- Version / Model
- 303-000134-24
- Company Name
- SKANRAY TECHNOLOGIES LIMITED
- Labeler DUNS
- 863358955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-26
- Public Version
- 2
- Public Version Date
- 2022-01-19
- Public Version Status
- Update
- Public Device Record Key
- 7a642618-8ac9-4016-a3b7-cd8733033322
Device Description
Intraskan DC Plus with 15" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiography for diagnostic purpose.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42297 | Stationary intraoral dental x-ray system, digital | A diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08904269400446 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170967 | 000 |