FDA UDI
In Commercial Distribution
🇺🇸 United States
AVRA 3-PC SET 3IN STERIS 3080 3085
DI: 00842430110641
·
Model: 69403AVS
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AVRA 3-PC SET 3IN STERIS 3080 3085
- Primary DI
- 00842430110641
- Version / Model
- 69403AVS
- Catalog Number
- 69403AVS
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-14
- Public Version
- 3
- Public Version Date
- 2023-09-19
- Public Version Status
- Update
- Public Device Record Key
- cbb65bbd-b7ed-4951-8aff-b75dced38c96
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 |
|---|---|---|---|---|
| JFC | System, Pressure Measurement, Intermittent | Physical Medicine | 890.1600 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65165 | Operating table patient pressure distribution data recorder/transceiver | An electronic hub designed to receive and record data related to a patient’s body pressure distribution on a pressure-sensing operating table mattress during a surgical procedure, and to transmit the data to a monitoring device for analysis and display. It is typically mounted onto the side of the operating table and receives electrical signals from the pressure-sensing mattress to which it is connected. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430110641 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 122 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 75 – 105 KiloPascal