Duns Number:246848147
Device Description: ABRA Silicone Cord Elastomer
Catalog Number
CZE07
Brand Name
Dynamic Tissue Systems™
Version/Model Number
CZE07
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"
Yes
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
KGS
Product Code Name
RETENTION DEVICE, SUTURE
Public Device Record Key
ed4871f9-b9b1-4d06-bfd1-5f8ead20d3b7
Public Version Date
December 28, 2020
Public Version Number
1
DI Record Publish Date
December 18, 2020
Package DI Number
10620974001864
Quantity per Package
2
Contains DI Package
00620974001867
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 | 91 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 2 |