Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Decontamination floor mat, reusable FDA UDI
- Device Name
- The surgeon, the assistant and the patient all have the potential to bring dust and bacteria into the operating room. The mat contains 30 disposable sheets. Simply peel off and dispose of each sheet when soiled. To prevent the spreading of bacterial contamination from room to room, HYGITECH has created a mat with an acrylic sticky surface treated with a substance which attacks and neutralises the bacterial content present in the residues retained by the mat. Advantages: - Non-slip PVC base - Numbered layers for checking the remaining capacity - Dimensions : 60x120cm FDA UDI
- Model / Reference
- HY-058 FDA UDI
- Description
- The surgeon, the assistant and the patient all have the potential to bring dust and bacteria into the operating room. The mat contains 30 disposable sheets. Simply peel off and dispose of each sheet when soiled. To prevent the spreading of bacterial contamination from room to room, HYGITECH has created a mat with an acrylic sticky surface treated with a substance which attacks and neutralises the bacterial content present in the residues retained by the mat. Advantages: - Non-slip PVC base - Numbered layers for checking the remaining capacity - Dimensions : 60x120cm FDA UDI
Identifiers
- Catalog Number
- HY-058 FDA UDI
- Primary DI / UDI-DI
- 03615140000345 FDA UDI
- FDA Product Code
- FXP FDA UDI
- GMDN Term
- Decontamination floor mat, reusable 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: Decontamination floor mat, reusable
Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI 17220d0f-25f0-42b6-a708-8beb85ada57a 34 fields · synced May 30, 2026