FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGITECH
DI: 03615140000222
·
Model: HY-90016
·
HYGITECH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYGITECH
- Primary DI
- 03615140000222
- Version / Model
- HY-90016
- Catalog Number
- HY-90016
- 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
- 33f58d4c-771d-4779-ba7d-b401716f363e
Device Description
Mayo tables are positioned right next to the surgeon and carry the implant motor. They can also be positioned over the patient, with the ability to be placed from one side only. HYGITECH Mayo table is built from durable, shiny stainless steel. The edges of the table have no lip, to allow the tubes coming from the motor to hang freely. • Tray dimensions: 73 cm x 47 cm x 3 cm • Dimensions between wheels: 36 cm front wheels, 32 cm rear wheels • Height (including wheels): 74.5cm • Adjustable height: from 74.5 cm to 117 cm • Weight: 13 kg
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 |
|---|---|---|---|---|
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13959 | Instrument table | A table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called "sterile area" of the operation site and in some cases may be attached to the operating table. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03615140000222 | GS1 |