Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- The 90cm Hygitech protective sleeve efficiently protects all tubing while guaranteeing the sterility of the operating room. These PVC single-use sleeves were specifically created with dental surgeons in mind. Characterisitics/Properties : - The sleeve’s dimensions allow the protection of tubing 90cm in length and 8,5cm in width - The sleeves contain an adhesive which giving good grip on the tubing - The box contains 250 sleeves Inpermeable surface protection - Effective barrier for non-autoclavable equiptment in order to combat cross-contamination - Protection against bacteria and viruses which limits the use of disinfectants and prolongs the lifespan of equiptment Strength - Rip Resistant Easy to use - Thanks to the adhesive at the end of the sleeves FDA UDI
- Model / Reference
- HY-066 FDA UDI
- Description
- The 90cm Hygitech protective sleeve efficiently protects all tubing while guaranteeing the sterility of the operating room. These PVC single-use sleeves were specifically created with dental surgeons in mind. Characterisitics/Properties : - The sleeve’s dimensions allow the protection of tubing 90cm in length and 8,5cm in width - The sleeves contain an adhesive which giving good grip on the tubing - The box contains 250 sleeves Inpermeable surface protection - Effective barrier for non-autoclavable equiptment in order to combat cross-contamination - Protection against bacteria and viruses which limits the use of disinfectants and prolongs the lifespan of equiptment Strength - Rip Resistant Easy to use - Thanks to the adhesive at the end of the sleeves FDA UDI
Identifiers
- Catalog Number
- HY-066 FDA UDI
- Primary DI / UDI-DI
- 03615140002899 FDA UDI
- FDA Product Code
- FXP FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use 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
No
FDA UDI
Category: Medical equipment/instrument drape, single-use
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 a758dc19-bfa9-4327-9b2b-5f61048356d3 34 fields · synced May 30, 2026