Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Oral lavage system FDA UDI
- Device Name
- HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. FDA UDI
- Model / Reference
- HY-110054 FDA UDI
- Description
- HYGITECH offers a complete range of irrigation sets compatible with most implantology motors on the market. Irrigation is an essential element of an implant surgery and limits the heating of bone and adjacent tissues. FDA UDI
Identifiers
- Catalog Number
- HY-110054 FDA UDI
- Primary DI / UDI-DI
- 03615140001670 FDA UDI
- FDA Product Code
- EFS FDA UDI
- GMDN Term
- Oral lavage system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oral lavage system
Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral lavage system.
- Waterpik Aquarius Professional Water Flosser — WATER PIK, INC. · Class I
- Waterpik Cordless Freedom Water Flosser — WATER PIK, INC. · Class I
- Waterpik UltraPlus and Cordless Express Water Flosser — WATER PIK, INC. · Class I
- Waterpik Cordless Enhance Water Flosser — WATER PIK, INC. · Class I
- Sejoy Oral Irrigator — JOYTECH HEALTHCARE CO., LTD · Class I
- Waterpik Cordless Water Flosser — WATER PIK, INC. · Class I
- Waterpik Ultra Plus Water Flosser — WATER PIK, INC. · Class I
- HealthSmart — DMS HOLDINGS, INC., · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI e586a7e2-330e-4746-9b62-144408b5c20e 34 fields · synced May 31, 2026