Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Shoe cover FDA UDI
- Device Name
- HYGITECH's newest overshoes are not only waterproof but economically packaged in 250 pairs. They protect the shoes of the dentists as well as the patients thanks to their impermeability. They also help to avoid all types of contaminations. Characteristics: -Waterproof -Unique Size 15x40 -500 in a pack (250 pairs) -Non sterile, Single use -Blue FDA UDI
- Model / Reference
- HY-50021 FDA UDI
- Description
- HYGITECH's newest overshoes are not only waterproof but economically packaged in 250 pairs. They protect the shoes of the dentists as well as the patients thanks to their impermeability. They also help to avoid all types of contaminations. Characteristics: -Waterproof -Unique Size 15x40 -500 in a pack (250 pairs) -Non sterile, Single use -Blue FDA UDI
Identifiers
- Catalog Number
- HY-50021 FDA UDI
- Primary DI / UDI-DI
- 03615140003049 FDA UDI
- FDA Product Code
- FXP FDA UDI
- GMDN Term
- Shoe cover 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: Shoe cover
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 3627cc9d-0c6f-478d-839b-b1007d395af2 34 fields · synced May 30, 2026