HYGITECH
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140005296
- Version / Model
- HY-09011
- Catalog Number
- HY-09011
- Company Name
- HYGITECH
- Labeler DUNS
- 279456896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-16
- Public Version
- 1
- Public Version Date
- 2020-12-24
- Public Version Status
- New
- Public Device Record Key
- d2b0ad4d-5c72-4372-9471-4a21a2123a34
Device Description
Duo kit HYGITECH Reference: HY-09011 The DUO kit is the kit needed for dressing both the surgeon and his assistant. some environment protection is also included, which makes this kit perfect for all kinds of procedures. The kit is composed of 32 items. 4 Polyethylene gloves 1 surgical drape (29.5"x 29.5"/ 75x75cm) 2 Elastic cap handle covers 2 Protective sleeves for tubing (3.5"x 47"/ 8x120cm) 3 non-latex elastic bands 1 Adhesive protective cover for control panel (6.3"x 8.9"/ 16x22cm) 1 surgical cap 2 Bouffant caps 2 tie-on masks 2 Pairs of overshoes 1 surgical brush with nail cleaner 4 Paper hand-towels 1 assistant gown with cotton cuffs 1 surgical gown with cotton cuffs 1 U-shaped surgical drape with adhesive (31.5"x 39"/ 80x100cm) 1 Wrapping paper
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11171 | Denture repair kit, professional | A collection of devices used in dentistry by a dentist or dental laboratory technician to repair cracks or breaks in a denture. It will contain the necessary materials and components, e.g., resins, adhesives/glues, mixing utensils, and an applicator. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03615140005302 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 03615140005296 | GS1 |