FDA UDI
In Commercial Distribution
🇺🇸 United States
REPLACEMENT HANA BASE, ASSY, 220V
DI: 00842430114731
·
Model: 6875-326i
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- REPLACEMENT HANA BASE, ASSY, 220V
- Primary DI
- 00842430114731
- Version / Model
- 6875-326i
- Catalog Number
- 6875-326I
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-25
- Public Version
- 3
- Public Version Date
- 2023-09-11
- Public Version Status
- Update
- Public Device Record Key
- 25bea97b-bd86-48d4-a451-4f7e56925cf6
Device Description
6875-326i = 6875-326I
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45400 | Orthopaedic operating table, electromechanical | A mobile, electrically-powered motorized table designed to support a patient and to provide traction for the limb(s)/spine of the patient during orthopaedic surgical procedures. Its surface consists of articulated sections that can be adjusted, and it is often intended to be used with additional patient positioners. It may have x-ray transparent features. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430114731 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 100 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -4 – 122 Degrees Fahrenheit