Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Skin surface device adhesive FDA UDI
- Device Name
- Convenient - Easy to tear off and apply Its delicate adhesive layer makes Hygifilm easily removable without damaging your equipment or walls. - Supplied as a roll of 10cm x 14,5xm pre-perforated adhesive sheets, presented in a dispenser box. In order to prevent cross-contamination, all surfaces that are likely to be touched by the medical team during the surgery should be covered. Hygifilm helps fight cross-contamination by isolating all surfaces that are impossible or difficult to autoclave: dental light handles, computer mice, computer control panel, keyboards and telephones... FDA UDI
- Model / Reference
- HY-055 FDA UDI
- Description
- Convenient - Easy to tear off and apply Its delicate adhesive layer makes Hygifilm easily removable without damaging your equipment or walls. - Supplied as a roll of 10cm x 14,5xm pre-perforated adhesive sheets, presented in a dispenser box. In order to prevent cross-contamination, all surfaces that are likely to be touched by the medical team during the surgery should be covered. Hygifilm helps fight cross-contamination by isolating all surfaces that are impossible or difficult to autoclave: dental light handles, computer mice, computer control panel, keyboards and telephones... FDA UDI
Identifiers
- Catalog Number
- HY-055 FDA UDI
- Primary DI / UDI-DI
- 03615140000321 FDA UDI
- FDA Product Code
- FTY FDA UDI
- GMDN Term
- Skin surface device adhesive 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
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: Skin surface device adhesive
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 ca625d7e-6315-4684-afd4-fc1cd2823f2a 34 fields · synced Jun 8, 2026