Duns Number:187502109
Device Description: 3MM XCEL WITH 1 STRAND #2 FORCE FIBER
Catalog Number
3910-300-015
Brand Name
Xcel
Version/Model Number
3910-300-015
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
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
K041307,K041307
Product Code
MAI
Product Code Name
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Public Device Record Key
2a9a3705-aad5-412b-b1d2-7d568ed8b57c
Public Version Date
March 21, 2019
Public Version Number
5
DI Record Publish Date
September 08, 2015
Package DI Number
37613154092605
Quantity per Package
5
Contains DI Package
07613154092604
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 |