FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140003810
·
Model: HY-634
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140003810
- Version / Model
- HY-634
- Catalog Number
- HY-634
- Company Name
- HYGITECH
- Labeler DUNS
- 279456896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-25
- Public Version
- 2
- Public Version Date
- 2020-12-15
- Public Version Status
- Update
- Public Device Record Key
- 6a5e8e91-4cdb-4970-a8a9-797be2da2e3c
Device Description
These drapes are composed of 2 layers: 1 absorbent spunlace layer (24g/m²) 1 waterproof PP layer (30g/m²) More info They can cover the equipment, Mayo tables, bridge tables and the patient Sticking on the shorter side For the whole range SURFACES PROTECTION For the product Effective barrier to fight against cross contaminations in non autoclavable elements, like dental chairs Protection against bacteria and viruses, it allows to limit the use of disinfectants and makes the equipment last longer 3 sizes, for all purposes Really strong and tear-resistant Compliant with the 13795-3 European norm
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 | 03615140003827 | GS1 | Box | 15 | In Commercial Distribution | |
| Primary | 03615140003810 | GS1 | ||||
| Package | 03615140003834 | GS1 | Carton | 2 | In Commercial Distribution |