FDA UDI
In Commercial Distribution
🇺🇸 United States
Foot and Ankle Stand
DI: 00860008892768
·
Model: G1
·
OXOS Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Foot and Ankle Stand
- Primary DI
- 00860008892768
- Version / Model
- G1
- Company Name
- OXOS Medical, Inc.
- Labeler DUNS
- 080323883
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-02
- Public Version
- 1
- Public Version Date
- 2025-06-10
- Public Version Status
- New
- Public Device Record Key
- 2e7b0b2e-c610-4797-9e12-b6be925a37d5
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
- No
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | Radiology | 892.1770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65313 | Diagnostic X-ray system positioning frame | An electrically-powered component of a diagnostic x-ray system intended to be placed on the floor to position and support a patient, an x-ray tube assembly, and an image receptor assembly (bucky) during a diagnostic x-ray procedure. It typically consists of a patient table, floor stands for the x-ray tube and image receptor, and controls. The table and floor stands may be moved and/or tilted; the image receptor may be included, however the x-ray tube is not included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008892768 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 29.9 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Altitude: Between 1000 ft below sea level and 8,000 ft above sea level
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity