Duns Number:315018218
Device Description: HEART XS Rib Spreader, complete set, consisting of FC132R, FC136R, FC137R, non-sterile, re HEART XS Rib Spreader, complete set, consisting of FC132R, FC136R, FC137R, non-sterile, reusable
Catalog Number
FC120R
Brand Name
HEART XS
Version/Model Number
FC120R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
-
Product Code
GAD
Product Code Name
RETRACTOR
Public Device Record Key
2712517c-e7a9-4605-a114-0905dead1df6
Public Version Date
September 26, 2022
Public Version Number
3
DI Record Publish Date
August 10, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |