Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Denture repair kit, professional FDA UDI
- Device Name
- Implanwear kit HYGITECH Reference: HY-08511 The IMPLANWEAR kit is intended for heavy implant surgeries involving a surgeon, an assistant and the patient. It contains all clothing items needed to protect 3 people. The kit is composed of 28 items. 2 Surgical hats 3 Bouffant caps 1 Pair of patient overshoes 2 Pairs of non-slip overshoes 3 Tie-on masks 2 Surgical brushes with nail cleaner 6 Paper hand-towels 1 Assistant gown with cotton cuffs 1 Patient gown with cotton cuffs 1 Surgical gown with cotton cuffs 1 Wrapping paper FDA UDI
- Model / Reference
- HY-08511 FDA UDI
- Description
- Implanwear kit HYGITECH Reference: HY-08511 The IMPLANWEAR kit is intended for heavy implant surgeries involving a surgeon, an assistant and the patient. It contains all clothing items needed to protect 3 people. The kit is composed of 28 items. 2 Surgical hats 3 Bouffant caps 1 Pair of patient overshoes 2 Pairs of non-slip overshoes 3 Tie-on masks 2 Surgical brushes with nail cleaner 6 Paper hand-towels 1 Assistant gown with cotton cuffs 1 Patient gown with cotton cuffs 1 Surgical gown with cotton cuffs 1 Wrapping paper FDA UDI
Identifiers
- Catalog Number
- HY-08511 FDA UDI
- Primary DI / UDI-DI
- 03615140005210 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 78ee11df-0060-4556-8ace-f73737665405 34 fields · synced May 30, 2026