HYGITECH
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140003865
- Version / Model
- HY-05902
- Catalog Number
- HY-05902
- Company Name
- HYGITECH
- Labeler DUNS
- 279456896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-15
- Public Version
- 1
- Public Version Date
- 2020-12-23
- Public Version Status
- New
- Public Device Record Key
- 00603291-5546-4da1-a990-34bcfb7d85f2
Device Description
Sterile transparent drape with adhesive HYGITECH Reference: HY-05902 Practical for all surgeries, the transparent sterile drape with adhesive allows the protection of the implantology motor or the control unit without compromising the sterility of the surgery. The transparency ensures you can keep an eye on the indications shown on the screen and easily change the programme. More info Characteristics : • 1 waterproof layer of polyethylene (65g/m²) • Dimensions: 40 (width) cm x 50 (length) cm • Adhesive: Located along the width of the drape(40 x 5 cm) Waterproof protection of surfaces -Effective barrier to fight against cross contaminations in non autoclavable elements. - Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longer Solidity - Resistant, does not tear
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
- No
- 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 |
|---|---|---|---|---|
| KKX | Drape, Surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33520 | Surgical drape adhesive | A spray, typically aerosol, intended to be applied to the skin to cause a surgical drape to adhere to the body. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03615140003872 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 03615140003865 | GS1 | ||||
| Package | 03615140003889 | GS1 | Carton | 4 | In Commercial Distribution |