Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Denture repair kit, professional FDA UDI
- Device Name
- Surgeon kit HYGITECH Reference: HY-0421 The SURGEON kit is specifically designed for surgeries with the surgeon operating on his own. It contains all the protection wear needed for the surgeon, as well as a surgical brush and towels. It is composed of 12 items. 1 Surgical hat 1 Bouffant cap 1 Tie-on mask 1 Pair of overshoes 1 Surgical brush with nail cleaner 3 Paper hand-towels 1 Surgical gown with cotton cuffs 1 Wrapping paper FDA UDI
- Model / Reference
- HY-0421 FDA UDI
- Description
- Surgeon kit HYGITECH Reference: HY-0421 The SURGEON kit is specifically designed for surgeries with the surgeon operating on his own. It contains all the protection wear needed for the surgeon, as well as a surgical brush and towels. It is composed of 12 items. 1 Surgical hat 1 Bouffant cap 1 Tie-on mask 1 Pair of overshoes 1 Surgical brush with nail cleaner 3 Paper hand-towels 1 Surgical gown with cotton cuffs 1 Wrapping paper FDA UDI
Identifiers
- Catalog Number
- HY-0421 FDA UDI
- Primary DI / UDI-DI
- 03615140005197 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 e308cbd6-4198-4a68-b76d-c09ee1719c01 34 fields · synced May 30, 2026