Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Surgical dressing/drape kit, single-use FDA UDI
- Device Name
- The PROTECT kit is HYGITECH’s best selling kit, designed to meet all needs for any type of implant surgery. The kit is composed of 45 items: 4 Polyethylene gloves 1 Instrument table cover (bridge) (90x120cm) 1 Surgical drape (75x75cm) 2 Protective sleeves for tubing (8cmx120cm) 1 Tube support with adhesive 2 Elastic cap handle covers 1 Protective PVC X-ray cover 2 Adhesive protective covers for control panel 3 Non-latex elastic bands 1 Adhesive film 5x80cm 1 Surgical hat 2 Bouffant caps 2 Tie-on masks 3 Pairs of overshoes 2 Sterile brushes with nail cleaner 6 Paper hand-towels 1 Surgical gown with cotton cuffs 1 Assistant gown with cotton cuffs 1 Patient gown with cotton cuffs 1 Surgical drape with aperture and adhesive (70x100cm) 1 U-shaped surgical drape with adhesive (100x150cm) 1 impermeable wrapping paper FDA UDI
- Model / Reference
- HY-0871 FDA UDI
- Description
- The PROTECT kit is HYGITECH’s best selling kit, designed to meet all needs for any type of implant surgery. The kit is composed of 45 items: 4 Polyethylene gloves 1 Instrument table cover (bridge) (90x120cm) 1 Surgical drape (75x75cm) 2 Protective sleeves for tubing (8cmx120cm) 1 Tube support with adhesive 2 Elastic cap handle covers 1 Protective PVC X-ray cover 2 Adhesive protective covers for control panel 3 Non-latex elastic bands 1 Adhesive film 5x80cm 1 Surgical hat 2 Bouffant caps 2 Tie-on masks 3 Pairs of overshoes 2 Sterile brushes with nail cleaner 6 Paper hand-towels 1 Surgical gown with cotton cuffs 1 Assistant gown with cotton cuffs 1 Patient gown with cotton cuffs 1 Surgical drape with aperture and adhesive (70x100cm) 1 U-shaped surgical drape with adhesive (100x150cm) 1 impermeable wrapping paper FDA UDI
Identifiers
- Catalog Number
- HY-0871 FDA UDI
- Primary DI / UDI-DI
- 03615140005258 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- Surgical dressing/drape kit, single-use 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: Surgical dressing/drape kit, 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 29bc11a7-5f11-4970-a2d6-d79dcb4f5215 34 fields · synced May 30, 2026