FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ZENTRUM HEAD SECTION WITH DRIVE, US
DI: 00842430108679
·
Model: 8000-20-U-D
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZENTRUM HEAD SECTION WITH DRIVE, US
- Primary DI
- 00842430108679
- Version / Model
- 8000-20-U-D
- Catalog Number
- 8000-20-U-D
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-27
- Public Version
- 4
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 78d6d1f3-9c11-4706-b878-034931fad0d9
- Distribution End Date
- 2024-01-26
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
- No
- 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
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDC | Table, Operating-Room, Electrical | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58055 | Operating/examination/treatment table headrest, reusable | A device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. This is a general-purpose headrest available in various shapes and sizes and might include mechanical mechanisms to enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430108679 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 23 – 113 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 75 – 105 KiloPascal