Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Surgical dressing/drape kit, single-use FDA UDI
- Device Name
- - Cost effective: These covers reduce the need to use disinfectants and protect the dental chair from bacteria, increasing the lifespan of the chair. - Convenient: A single, universal, easy-to-use cover for all 3 parts of the dental chair (6 fixing straps) - Comfortable and waterproof: it creates a pleasant looking and hygienic environment, giving the patient a feeling of safety and cleanliness. FDA UDI
- Model / Reference
- HY-60035 FDA UDI
- Description
- - Cost effective: These covers reduce the need to use disinfectants and protect the dental chair from bacteria, increasing the lifespan of the chair. - Convenient: A single, universal, easy-to-use cover for all 3 parts of the dental chair (6 fixing straps) - Comfortable and waterproof: it creates a pleasant looking and hygienic environment, giving the patient a feeling of safety and cleanliness. FDA UDI
Identifiers
- Catalog Number
- HY-60035 FDA UDI
- Primary DI / UDI-DI
- 03615140003216 FDA UDI
- FDA Product Code
- FXP FDA UDI
- GMDN Term
- Surgical dressing/drape kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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: Surgical dressing/drape kit, single-use
Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical dressing/drape kit, single-use.
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- PureLife+ 2-Ply Dental Bibs — PURELIFE, LLC · Class I
- AD Surgical — APPLIED DENTAL, INC. · Class II
- PureLife+ 2-Ply Dental Bibs — PURELIFE, LLC · Class I
- PureLife+ 2-Ply Dental Bibs — PURELIFE, LLC · Class I
- AD Surgical — APPLIED DENTAL, INC. · Class II
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 cbb18a45-eb5d-4d50-a77d-85a9bc8b2145 34 fields · synced May 30, 2026