Duns Number:808875397
Device Description: Fibreplast Hd+Shldr Portrait S-Frame, 3.2mm Std Perf w/ Integrated Shim
Catalog Number
RT-A892KSD
Brand Name
Fibreplast® with Integrated Shim™
Version/Model Number
RT-A892KSD
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"
-
For Single-Use
Yes
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
K935067,K935067
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
54383b99-864e-4ffa-a545-b27173405cde
Public Version Date
December 28, 2021
Public Version Number
1
DI Record Publish Date
December 20, 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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 998 |