Duns Number:078671236
Device Description: The Straight Arm is an economical and space-efficient X-ray system that can perform a comp The Straight Arm is an economical and space-efficient X-ray system that can perform a comprehensive range of radiographic procedures.Its flexibility permits imaging of patients sitting or standing, as well as recumbent when optional mobile table is present
Catalog Number
-
Brand Name
Straight Arm
Version/Model Number
SARM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IXY
Product Code Name
Holder, Radiographic Cassette, Wall-Mounted
Public Device Record Key
1b89c4ba-4a31-439d-88ab-264fb59e06ad
Public Version Date
June 22, 2021
Public Version Number
1
DI Record Publish Date
June 14, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |