Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Surgical dressing/drape kit, single-use FDA UDI
- Device Name
- Effective and comfortable waterproof protection for the patient White cover with elastic lining, easy to fix on the dental chair keeping the handle uncovered Favours the impression of cleanness and care for hygiene of the surgery Fits any kind of dental chair, 24cm diameter More info Resistant, does not tear: polypropylene (12g/m² ), coated with polyethylene (18g/m² ) Easy to stock: boxes of 50 pieces each Allows to limit the use of disinfectants and makes the dental chair last longer Dispenser box FDA UDI
- Model / Reference
- HY-60060 FDA UDI
- Description
- Effective and comfortable waterproof protection for the patient White cover with elastic lining, easy to fix on the dental chair keeping the handle uncovered Favours the impression of cleanness and care for hygiene of the surgery Fits any kind of dental chair, 24cm diameter More info Resistant, does not tear: polypropylene (12g/m² ), coated with polyethylene (18g/m² ) Easy to stock: boxes of 50 pieces each Allows to limit the use of disinfectants and makes the dental chair last longer Dispenser box FDA UDI
Identifiers
- Catalog Number
- HY-60060 FDA UDI
- Primary DI / UDI-DI
- 03615140003841 FDA UDI
- FDA Product Code
- EGN FDA UDI
- GMDN Term
- Surgical dressing/drape kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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: Surgical dressing/drape kit, single-use
Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical dressing/drape kit, single-use.
- PureLife+ 2-Ply Dental Bibs — PURELIFE, LLC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- ASK-1 Aspiration Starter Kit — RANFAC CORP. · Class II
- PureLife+ 2-Ply Dental Bibs — PURELIFE, LLC · Class I
- AD Surgical — APPLIED DENTAL, INC. · Class II
- PureLife+ 2-Ply Dental Bibs — PURELIFE, LLC · Class I
- PureLife+ 2-Ply Dental Bibs — PURELIFE, LLC · Class I
- AD Surgical — APPLIED DENTAL, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI 6cbb427f-a5c5-45b2-812b-c6f81d3a1123 34 fields · synced May 30, 2026