Identity
- Trade Name
- DTE FDA UDI
- Generic Name
- Diagnostic x-ray system generator, hand-held FDA UDI
- Device Name
- Dental X-Ray Device FDA UDI
- Model / Reference
- Mini Ray FDA UDI
- Description
- Dental X-Ray Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843658124 FDA UDI
- 510(k) Number
- K222569 FDA UDI
- FDA Product Code
- EHD FDA UDI
- GMDN Term
- Diagnostic x-ray system generator, hand-held FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Diagnostic x-ray system generator, hand-held
Dte by Guilin Woodpecker Medical Instrument Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Diagnostic x-ray system generator, hand-held.
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- NOMAD MD™ handheld X-ray system — ARIBEX, INC. · Class II
- NOMAD™ handheld X-ray system — ARIBEX, INC. · Class II
- NOMAD™ handheld X-ray system — ARIBEX, INC. · Class II
- Nomad Pro2 Packaged System, GBL — Dental Imaging Technologies Corporation · Class II
Cleared under the same submission
K222569 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Guilin Woodpecker Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI 89c90060-f494-412c-adbc-49c3e79db215 34 fields · synced May 30, 2026