Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Denture repair kit, professional FDA UDI
- Device Name
- Visit kit HYGITECH Reference: HY-03811 The VISIT kit is specifically designed for short dental procedures. It contains comprehensive protective clothing for either the surgeon, the assistant or the patient. It is composed of 10 items. More info 1 Bouffant cap 1 Surgical hat 1 Tie-on mask 3 Paper hand-towels 1 Surgical gown with cotton cuffs 1 Pair of overshoes 1 Wrapping pape FDA UDI
- Model / Reference
- HY-03811 FDA UDI
- Description
- Visit kit HYGITECH Reference: HY-03811 The VISIT kit is specifically designed for short dental procedures. It contains comprehensive protective clothing for either the surgeon, the assistant or the patient. It is composed of 10 items. More info 1 Bouffant cap 1 Surgical hat 1 Tie-on mask 3 Paper hand-towels 1 Surgical gown with cotton cuffs 1 Pair of overshoes 1 Wrapping pape FDA UDI
Identifiers
- Catalog Number
- HY-03811 FDA UDI
- Primary DI / UDI-DI
- 03615140005326 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Denture repair kit, professional FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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: Denture repair kit, professional
Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI f65001fc-65e1-4ff4-872e-488c8432f8a9 34 fields · synced May 30, 2026