Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Face splash shield, single-use FDA UDI
- Device Name
- Total protection of the face, eyes and forehead Elastic 3 ply mask with nose clip, EN 14683 Fully transparent panoramic visor No glass fibres, latex-free, odourless . Comfortable: flexible nose piece sheathed steel 9cm High strength visor stitched to the mask Anti-fog treatment on the inside and front of the shield Doesn't affect vision during procedure Perfect protection: 30cm wrap-around visor Lightweight: 11g Can be worn with precription glasses Packed individually keeping the visors in perfect condition FDA UDI
- Model / Reference
- HY-07011 FDA UDI
- Description
- Total protection of the face, eyes and forehead Elastic 3 ply mask with nose clip, EN 14683 Fully transparent panoramic visor No glass fibres, latex-free, odourless . Comfortable: flexible nose piece sheathed steel 9cm High strength visor stitched to the mask Anti-fog treatment on the inside and front of the shield Doesn't affect vision during procedure Perfect protection: 30cm wrap-around visor Lightweight: 11g Can be worn with precription glasses Packed individually keeping the visors in perfect condition FDA UDI
Identifiers
- Catalog Number
- HY-07011 FDA UDI
- Primary DI / UDI-DI
- 03615140000406 FDA UDI
- 510(k) Number
- K173062 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Face splash shield, single-use FDA UDI
Classification
- Device Class
- Class II 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Face splash shield, single-use
Hygitech by Hygitech — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI 669f185a-26e1-4b54-8452-e815151d1d04 35 fields · synced May 29, 2026