Duns Number:006261481
Device Description: BAND SIM SRB 800SC34 SEMI-RIGID 34MM
Catalog Number
-
Brand Name
ATS SIMULUS®
Version/Model Number
800SC34
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 24, 2018
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K083683
Product Code
KRH
Product Code Name
RING, ANNULOPLASTY
Public Device Record Key
6b3d7183-1eca-495a-b7a5-3c341a90b0af
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
June 18, 2015
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |