FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140003841
·
Model: HY-60060
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140003841
- Version / Model
- HY-60060
- Catalog Number
- HY-60060
- 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
- 6cbb427f-a5c5-45b2-812b-c6f81d3a1123
Device Description
Effective and comfortable waterproof protection for the patient White cover with elastic lining, easy to fix on the dental chair keeping the handle uncovered Favours the impression of cleanness and care for hygiene of the surgery Fits any kind of dental chair, 24cm diameter More info Resistant, does not tear: polypropylene (12g/m² ), coated with polyethylene (18g/m² ) Easy to stock: boxes of 50 pieces each Allows to limit the use of disinfectants and makes the dental chair last longer Dispenser box
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 |
|---|---|---|---|---|
| EGN | Scissors, Surgical Tissue, Dental | Dental | 872.4565 | 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 | 03615140003858 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 03615140003841 | GS1 |