Duns Number:117630237
Device Description: ForceBraid™ Suture Tape, Blue, 20"
Catalog Number
-
Brand Name
ForceBraid™
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150438,K150438
Product Code
GAT
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Public Device Record Key
536a5ceb-2153-4ffe-b6a9-07f58743095f
Public Version Date
February 25, 2021
Public Version Number
6
DI Record Publish Date
March 14, 2016
Package DI Number
B048VAL2020BT1
Quantity per Package
6
Contains DI Package
B048VAL2020BT0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 90 |
2 | A medical device with a moderate to high risk that requires special controls. | 162 |