Duns Number:006261481
Device Description: Ring 7700FR34 SimuPlus Flex 34mm GLB
Catalog Number
-
Brand Name
SimuPlus™
Version/Model Number
7700FR34
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
K201449
Product Code
KRH
Product Code Name
RING, ANNULOPLASTY
Public Device Record Key
6f4b46f5-c744-4824-9238-9a5ac8c73f2f
Public Version Date
May 24, 2021
Public Version Number
1
DI Record Publish Date
May 15, 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 | 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 |