FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140002837
·
Model: HY-060
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140002837
- Version / Model
- HY-060
- Catalog Number
- HY-060
- 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
- 2
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 7bbb6879-ac9f-4bbd-b26e-29fcedbb2f27
Device Description
HYGITECH polyethylene protection sleeves enable you to cover hand pieces, cables, turbines and contra-angles. Effective barrier to fight against cross contamination. Practical: Sleeves are easily separated one from another via the dispenser box. Resistant and easy to use. Sleeves must to be changed after every patient Dimensions: 4.5 or 5,5cm x45 cm long, Ø2.8 cm, conical end Ø1.5cm
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 |
|---|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10035 | Skin surface device adhesive | A substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. 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 | 03615140002844 | GS1 | Carton | 18 | In Commercial Distribution | |
| Primary | 03615140002837 | GS1 |