HYGITECH
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140005173
- Version / Model
- HY-0991
- Catalog Number
- HY-0991
- 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
- a9c1321c-b8cf-4d9c-95ad-f98374d85f1d
Device Description
Protect Extend kit Reference: HY-0991 The HYGITECH Protect Extend kit responds to all needs of implant surgery. We’ve now added to our best seller HYGITECH Protect kit 3 essential elements for implant surgery : -A universal irrigation set -An aspiration set with tube and yankauer cannula -A 2,5mm cannula and adaptor The kit is composed of 49 items: 1 4 Polyethylene gloves 2 2 Tie-on masks 3 1 Surgical hat 4 2 Bouffant caps 5 1 Surgical gown with cotton cuffs 6 1 Assistant gown with cotton cuffs 7 1 Patient gown with cotton cuffs 8 3 Pairs of overshoes 9 2 Sterile brushes with nail cleaner 10 6 Paper hand-towels 11 1 Surgical drape (75x75cm) 1 Instrument table cover (bridge) (90x120cm) 1 U-shaped surgical drape with adhesive (100x150cm) 1 Surgical drape with aperture and adhesive (70x100cm) 2 Protective sleeves for tubing (8cmx120cm) 3 Non-latex elastic bands 1 Adhesive film (5cmx80cm) 2 Elastic cap handle covers 2 Adhesive protective covers for control panel 1 Tube support with adhesive 1 Protective PVC X-ray cover 1 universal irrigation set 1 2,5mm cannula with adaptor 1 aspiration set with cannula 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 | 03615140005180 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 03615140005173 | GS1 |