Duns Number:187502109
Device Description: 2.0MM XBRAID TT, 100% UHMWPE, VIOLET
Catalog Number
3910-900-019
Brand Name
XBraid
Version/Model Number
3910-900-019
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
-
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
530d44d5-48c7-4ebe-9454-50bd4963a848
Public Version Date
March 21, 2019
Public Version Number
4
DI Record Publish Date
November 19, 2015
Package DI Number
37613327261494
Quantity per Package
12
Contains DI Package
07613327261493
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |