Duns Number:945020902
Catalog Number
-
Brand Name
Regard™
Version/Model Number
GS1031
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 26, 2020
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
-
Product Code
FDE
Product Code Name
Laparoscopy Kit
Public Device Record Key
9f706162-0674-4da2-9c11-a8b7ebd53463
Public Version Date
August 27, 2020
Public Version Number
2
DI Record Publish Date
March 27, 2018
Package DI Number
20326053115176
Quantity per Package
1
Contains DI Package
10326053115179
Package Discontinue Date
August 26, 2020
Package Status
Not 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 | 305 |
2 | A medical device with a moderate to high risk that requires special controls. | 558 |