Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Denture repair kit, professional FDA UDI
- Device Name
- Duo kit HYGITECH Reference: HY-09011 The DUO kit is the kit needed for dressing both the surgeon and his assistant. some environment protection is also included, which makes this kit perfect for all kinds of procedures. The kit is composed of 32 items. 4 Polyethylene gloves 1 surgical drape (29.5"x 29.5"/ 75x75cm) 2 Elastic cap handle covers 2 Protective sleeves for tubing (3.5"x 47"/ 8x120cm) 3 non-latex elastic bands 1 Adhesive protective cover for control panel (6.3"x 8.9"/ 16x22cm) 1 surgical cap 2 Bouffant caps 2 tie-on masks 2 Pairs of overshoes 1 surgical brush with nail cleaner 4 Paper hand-towels 1 assistant gown with cotton cuffs 1 surgical gown with cotton cuffs 1 U-shaped surgical drape with adhesive (31.5"x 39"/ 80x100cm) 1 Wrapping paper FDA UDI
- Model / Reference
- HY-09011 FDA UDI
- Description
- Duo kit HYGITECH Reference: HY-09011 The DUO kit is the kit needed for dressing both the surgeon and his assistant. some environment protection is also included, which makes this kit perfect for all kinds of procedures. The kit is composed of 32 items. 4 Polyethylene gloves 1 surgical drape (29.5"x 29.5"/ 75x75cm) 2 Elastic cap handle covers 2 Protective sleeves for tubing (3.5"x 47"/ 8x120cm) 3 non-latex elastic bands 1 Adhesive protective cover for control panel (6.3"x 8.9"/ 16x22cm) 1 surgical cap 2 Bouffant caps 2 tie-on masks 2 Pairs of overshoes 1 surgical brush with nail cleaner 4 Paper hand-towels 1 assistant gown with cotton cuffs 1 surgical gown with cotton cuffs 1 U-shaped surgical drape with adhesive (31.5"x 39"/ 80x100cm) 1 Wrapping paper FDA UDI
Identifiers
- Catalog Number
- HY-09011 FDA UDI
- Primary DI / UDI-DI
- 03615140005296 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 d2b0ad4d-5c72-4372-9471-4a21a2123a34 34 fields · synced May 30, 2026