FDA UDI
Not in Commercial Distribution
🇺🇸 United States
XR-600 Basic
DI: 00866955000409
·
Model: 600
·
Norland at Swissray
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- XR-600 Basic
- Primary DI
- 00866955000409
- Version / Model
- 600
- Company Name
- Norland at Swissray
- Labeler DUNS
- 110329096
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-16
- Public Version
- 4
- Public Version Date
- 2026-01-30
- Public Version Status
- Update
- Public Device Record Key
- 3957cbfa-cbfd-431b-875f-6b097279a0e9
- Distribution End Date
- 2021-12-31
Device Description
XR-600 Basic Bone Densitometer
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| KGI | Densitometer, Bone | Radiology | 892.1170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37661 | Bone absorptiometric x-ray system, dual-energy | An assembly of devices designed for bone density measurements and other calculations based on data obtained using a two distinct photon energy peak. Also referred to as a bone densitometer. It utilizes an x-ray tube or tubes as the photon source which are mechanically aligned and moves along with a photon detector assembly typically in a rectilinear pattern. The collimated beam is directed through an anatomical region of interest and the differential absorption patterns are detected. This information is used in calculations to estimate bone mineral density (osteoporosis), subcutaneous fat, fracture risk. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00866955000409 | GS1 |
Customer Contacts
- Phone
- 920-563-8456
- [email protected]