Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Surgical drape adhesive FDA UDI
- Device Name
- These drapes are composed of 2 layers: 1 absorbent spunlace layer (24g/m²) 1 waterproof PP layer (30g/m²) More info They can cover the equipment, Mayo tables, bridge tables and the patient Sticking on the shorter side For the whole range SURFACES PROTECTION For the product Effective barrier to fight against cross contaminations in non autoclavable elements, like dental chairs Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longer 3 sizes, for all purposes Really strong and tear-resistant Compliant with the 13795-3 European norm FDA UDI
- Model / Reference
- HY-634 FDA UDI
- Description
- These drapes are composed of 2 layers: 1 absorbent spunlace layer (24g/m²) 1 waterproof PP layer (30g/m²) More info They can cover the equipment, Mayo tables, bridge tables and the patient Sticking on the shorter side For the whole range SURFACES PROTECTION For the product Effective barrier to fight against cross contaminations in non autoclavable elements, like dental chairs Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longer 3 sizes, for all purposes Really strong and tear-resistant Compliant with the 13795-3 European norm FDA UDI
Identifiers
- Catalog Number
- HY-634 FDA UDI
- Primary DI / UDI-DI
- 03615140003810 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Surgical drape adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
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: Surgical drape adhesive
Hygitech by Hygitech — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI 6a5e8e91-4cdb-4970-a8a9-797be2da2e3c 34 fields · synced May 30, 2026