HYGITECH
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140005258
- Version / Model
- HY-0871
- Catalog Number
- HY-0871
- Company Name
- HYGITECH
- Labeler DUNS
- 279456896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-14
- Public Version
- 3
- Public Version Date
- 2021-06-22
- Public Version Status
- Update
- Public Device Record Key
- 29bc11a7-5f11-4970-a2d6-d79dcb4f5215
Device 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
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 |
|---|---|---|---|---|
| 62934 | Surgical dressing/drape kit, single-use | A collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03615140005265 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 03615140005258 | GS1 |