FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140000406
·
Model: HY-07011
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140000406
- Version / Model
- HY-07011
- Catalog Number
- HY-07011
- 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
- 669f185a-26e1-4b54-8452-e815151d1d04
Device Description
Total protection of the face, eyes and forehead Elastic 3 ply mask with nose clip, EN 14683 Fully transparent panoramic visor No glass fibres, latex-free, odourless . Comfortable: flexible nose piece sheathed steel 9cm High strength visor stitched to the mask Anti-fog treatment on the inside and front of the shield Doesn't affect vision during procedure Perfect protection: 30cm wrap-around visor Lightweight: 11g Can be worn with precription glasses Packed individually keeping the visors in perfect condition
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FXX | Mask, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11961 | Face splash shield, single-use | A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03615140000413 | GS1 | Carton | 18 | In Commercial Distribution | |
| Primary | 03615140000406 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173062 | 000 |