FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AVRA HEAD 3IN SKYTRON 3501,3600,3602
DI: 00842430110344
·
Model: 69483AVH
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AVRA HEAD 3IN SKYTRON 3501,3600,3602
- Primary DI
- 00842430110344
- Version / Model
- 69483AVH
- Catalog Number
- 69483AVH
- 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
- 2021-06-18
- Public Version
- 3
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- c4393ded-b43e-4166-ac4e-807972a0929e
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JFC | System, Pressure Measurement, Intermittent | Physical Medicine | 890.1600 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65164 | Operating table mattress, pressure-sensing | An electrically-powered cushioned mattress with pressure-sensing properties designed to be placed on top of an operating table to serve as the surface upon which the patient is placed, and to map the patient’s body pressure distribution on its surface during a surgical procedure; the gathered data is transmitted to a pressure monitoring hub/tablet for analysis and display. The device is constructed with a pressure-sensitive fabric and is available in pads of different lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430110344 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 75 – 105 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 122 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity