FDA UDI
In Commercial Distribution
🇺🇸 United States
AURA 10 PET-CT
DI: 05430002734026
·
Model: A
·
Xeos Medical
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AURA 10 PET-CT
- Primary DI
- 05430002734026
- Version / Model
- A
- Company Name
- Xeos Medical
- Labeler DUNS
- 371941719
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-09
- Public Version
- 1
- Public Version Date
- 2024-01-17
- Public Version Status
- New
- Public Device Record Key
- d832d7c5-7e9c-40fe-93d2-5f37f3615cea
Device Description
Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
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
- 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 |
|---|---|---|---|---|
| QXL | Cabinet, Emission Computed Tomography System | Radiology | 892.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62011 | Instrument/analyser specimen/reagent container carrier IVD | A device intended to hold a specimen/reagent container (e.g., test tube, tissue specimen petri dish, microplate, cuvette) on board an in vitro diagnostic laboratory instrument or analyser (e.g., PCR machine, spectrophotometric plate reader, biopsy specimen analyser, automated liquid handling station). It may be in the form of a removable tray (excludes immunoassay vehicle trays), holder, shuttle, rack/rack base, slotted case, or other format suitable to be handled and loaded into the parent device by the operator or via an automated process. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15430002734023 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 05430002734026 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231420 | 000 |