FDA UDI
In Commercial Distribution
🇺🇸 United States
X-CEL X-RAY CORPORATION
DI: B216MB715NT1
·
Model: MB-715NT
·
ARQUILLA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- X-CEL X-RAY CORPORATION
- Primary DI
- B216MB715NT1
- Version / Model
- MB-715NT
- Company Name
- ARQUILLA, INC.
- Labeler DUNS
- 062469945
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0a8fe3e2-cc81-4c33-95ee-5584f925e89b
Device Description
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
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 |
|---|---|---|---|---|
| KPR | System, X-Ray, Stationary | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37644 | Stationary basic diagnostic x-ray system, analogue | An assembly of devices that comprise a general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It is typically an x-ray film based system that use analogue or analogue-to-digital techniques for image capture and display. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (mobile imaging facility). This system consists of modular configurations that can be upgraded by the addition of hardware/software components 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 | B216MB715NT1 | HIBCC |
Customer Contacts
- Phone
- 8154552470
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K811230 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit