Duns Number:489730120
Device Description: ThoraxSupport, 2P, extended cushion aperture, adjustable lower arm supports with high armc ThoraxSupport, 2P, extended cushion aperture, adjustable lower arm supports with high armcup, adjustable cranial arm supports with high armcup, integrated mask fixation points
Catalog Number
122100
Brand Name
ThoraxSupport™
Version/Model Number
LB1C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142420
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
c98ff92c-7c45-44d9-b098-78a20a86efcf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 31, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 114 |