Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Skin surface device adhesive FDA UDI
- Device Name
- In order to prevent cross-contamination, all surfaces that are likely to be touched by the medical team during the surgery should be covered. The protection film helps fight cross-contamination by becoming a valid protection barrier for all the surfaces. Convenient: Easy to tear off and apply. Its delicate adhesive layer makes the protecttion film easily removable without damaging your equipment or walls. Supplied as a box of 50 adhesive sheets of 16 x 22.50 cm. FDA UDI
- Model / Reference
- HY-05702 FDA UDI
- Description
- In order to prevent cross-contamination, all surfaces that are likely to be touched by the medical team during the surgery should be covered. The protection film helps fight cross-contamination by becoming a valid protection barrier for all the surfaces. Convenient: Easy to tear off and apply. Its delicate adhesive layer makes the protecttion film easily removable without damaging your equipment or walls. Supplied as a box of 50 adhesive sheets of 16 x 22.50 cm. FDA UDI
Identifiers
- Catalog Number
- HY-05702 FDA UDI
- Primary DI / UDI-DI
- 03615140002721 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
Yes
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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Also classified as Skin surface device adhesive.
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- Protecta-Gel® — J.R.J. MEDICAL INNOVATIONS, LLC · Class I
- POPS — TRIFECTA THERAPEUTICS LLC · Class I
- ViveCare — VIVE HEALTH LLC · Class I
- ViveCare — VIVE HEALTH LLC · Class I
- Uro-Bond® V Brush-On Non-Flammable Silicone Adhesive 1.5 oz. (44.4 mL.) — UROCARE PRODUCTS, INC. · Class I
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 d77e31c5-4b29-472c-97f4-ad7fe61526a3 34 fields · synced May 30, 2026