FDA UDI
In Commercial Distribution
🇺🇸 United States
KneeAlign 2
DI: 00858704006008
·
Model: 133631
·
ORTHALIGN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- KneeAlign 2
- Primary DI
- 00858704006008
- Version / Model
- 133631
- Catalog Number
- 133631
- Company Name
- ORTHALIGN, INC.
- Labeler DUNS
- 023266163
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2022-03-21
- Public Version Status
- Update
- Public Device Record Key
- dfaf658a-f618-46d3-90f7-18080926324f
Device Description
KneeAlign 2 Unit
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45200 | Orthopaedic stereotactic surgery system | An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10858704006005 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00858704006008 | GS1 |
Customer Contacts
- Phone
- 866-582-0879
- [email protected]
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 60 – 101 KiloPascal