Duns Number:080356428
Catalog Number
XI1116B-S+
Brand Name
Colorado Therapeutics Xenograft Implant
Version/Model Number
XI-S+
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
-
Product Code
FTM
Product Code Name
Mesh, Surgical
Public Device Record Key
3fd9598f-39b0-4d57-9afd-c6ecbe4d0f0d
Public Version Date
September 20, 2019
Public Version Number
1
DI Record Publish Date
September 12, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 12 |