FDA UDI
In Commercial Distribution
🇺🇸 United States
Micro C Medical Imaging System, M01
DI: 00860001123401
·
Model: M01
·
Oxos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Micro C Medical Imaging System, M01
- Primary DI
- 00860001123401
- Version / Model
- M01
- Company Name
- Oxos Medical, Inc.
- Labeler DUNS
- 080323883
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-08
- Public Version
- 2
- Public Version Date
- 2022-03-17
- Public Version Status
- Update
- Public Device Record Key
- b9bda0c7-d3d7-4a94-b513-e10cdf3f5c6e
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| IZL | System, X-Ray, Mobile | Radiology | 892.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37658 | Hand-held basic diagnostic x-ray system, digital | An assembly of devices that comprise a digital general-purpose hand-held diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture and display and manipulation. It typically operates on battery power and is designed to be easily carried from location to location by a single operator. It is most commonly used in sports medicine or military applications. It consists of a modular configuration that can be upgraded by the addition of hardware or software components and/or accessories. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860001123401 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 33 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity