Duns Number:808875397
Device Description: Encompass Head Only Open View Thermoplastic System
Catalog Number
RT-B889KYCF
Brand Name
Encompass™ SRS Fibreplast™ System
Version/Model Number
RT-B889KYCF
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
K152321,K152321
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
8f5ad555-e31f-42c0-abb4-2bf58ba65206
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 13, 2021
Package DI Number
30841962140288
Quantity per Package
5
Contains DI Package
10841962111406
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |