FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140000086
·
Model: HY-90070
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140000086
- Version / Model
- HY-90070
- Catalog Number
- HY-90070
- 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
- 1
- Public Version Date
- 2020-12-22
- Public Version Status
- New
- Public Device Record Key
- c74ba0ce-2b15-4df5-9e3c-f52374b2931f
Device Description
The infusion stand is ideal for irrigation during implant surgery. Manual height adjustment: max 2 meters More info Total diameter: 30 mm Wheelbase: 52 cm Maximum load per hook: 6kg 2 year warranty Made in France
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10298 | Bowl/basin stand | A device that typically consists of a framework designed to support a bowl or basin in a recess at the top of the device. The stand may be stationary or mobile and is typically used in operating theatres, examination rooms, accident and emergency (A&E) rooms, or bedside. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03615140000086 | GS1 |