FDA UDI
In Commercial Distribution
🇺🇸 United States
ADX4000; iRay D4
DI: 08800000500010
·
Model: ADX4000; ADX4000W
·
DEXCOWIN CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ADX4000; iRay D4
- Primary DI
- 08800000500010
- Version / Model
- ADX4000; ADX4000W
- Company Name
- DEXCOWIN CO., LTD.
- Labeler DUNS
- 690327239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 28557721-7196-4d80-b7a6-592279220bfc
Device Description
Portable x-ray system intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure for both pediatric and adult patients.
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MUH | System,X-Ray,Extraoral Source,Digital | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37606 | Diagnostic x-ray system generator, portable | An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800000500010 | GS1 |
Customer Contacts
- Phone
- 626-993-6716
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K134055 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius