HYGITECH
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140002462
- Version / Model
- HY-0861
- Catalog Number
- HY-0861
- Company Name
- HYGITECH
- Labeler DUNS
- 279456896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-24
- Public Version
- 2
- Public Version Date
- 2020-12-15
- Public Version Status
- Update
- Public Device Record Key
- 2ebc2c06-de7f-439f-a607-4017cbd77459
Device Description
The IMPLANFIELD kit is designed for protecting the operating theatre. It is recommended for surgeries that are not implantology- or endodontology-specific. Indeed, these surgeries do not usually require an operating room meaning there are more surfaces to cover. The kit is composed of 25 items: 1 4 Polyethylene gloves 2 1 Plastic bag (50x80cm) 3 2 Adhesive films (5x80cm) 4 1 Tube support with adhesive 5 3 Protective sleeves for tubing (8x120cm) 6 1 Adhesive protective cover for control panel 7 2 Elastic cap handle covers 8 1 Protective PVC X-ray cover 9 2 Surgical drapes (75x75cm) 10 1 Instrument table cover (90x120cm) 11 1 Instrument table cover (bridge) (100x180cm) 12 1 Surgical drape with aperture and adhesive (75x90cm) 13 1 U-shaped surgical drape with adhesive (100x150cm) 14 3 Non-latex elastic bands 15 1 Wrapping paper The IMPLANFIELD kit is complementary to the IMPLANWEAR kit, which contains all clothing protection for the operation. The materials # Polypropylene non woven fabric # Laminated non-woven fabric # SMS Microfibre # Crepe 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 | 03615140002479 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 03615140002462 | GS1 |