FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140003636
·
Model: HY-60042
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140003636
- Version / Model
- HY-60042
- Catalog Number
- HY-60042
- 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
- 4
- Public Version Date
- 2021-06-22
- Public Version Status
- Update
- Public Device Record Key
- c800681d-0447-4a53-a6fe-39d6757af640
Device Description
Dental chair covers provide an effective barrier against bacteria, protecting the patient from cross-infection. HYGITECH supplies both sterile and non-sterile chair covers. Benefits: For the surgeon: Cost effective: These covers reduce the need to use disinfectants and protect the dental chair from bacteria, increasing the lifespan of the chair. Convenient: A single, universal, easy-to-use cover for all 3 parts of the dental chair (6 fixing straps) For the patient: Comfortable and waterproof: it creates a pleasant looking and hygienic environment, giving the patient a feeling of safety and cleanliness.
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | 878.4040 | 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 | 03615140003643 | GS1 | Box | 30 | In Commercial Distribution | |
| Primary | 03615140003636 | GS1 | ||||
| Package | 03615140003650 | GS1 | Carton | 2 | In Commercial Distribution |