FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140000109
·
Model: HY-90090
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140000109
- Version / Model
- HY-90090
- Catalog Number
- HY-90090
- 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
- 6a4bb7e6-d0d2-4834-95cd-d8ed535c194c
Device Description
HYGITECH waste bucket is made of stainless steel 18/10 AISI 304. Great mobility: 4 wheels of 50mm diameter Easy to clean: The bowl is detachable from the base. Capacity: 14L
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 |
|---|---|---|---|---|
| 14427 | Kick bucket | A device typically made of stainless steel that is used as a receptacle for refuse in an operating room (OR) or treatment room where surgery is performed. The refuse is typically packaging, plastic coverings, or cotton balls. Surgical sponges are not generally thrown into this device as they should be accounted for and collected on a special rack until the end of the intervention. The device is typically mounted in a low stand with wheels so that it may be easily moved with a kick of the foot, hence the name "kick bucket". A liner is usually used to improve hygiene. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03615140000109 | GS1 |