Duns Number:228209805
Device Description: Poly-Tape 10mm x 800mm
Catalog Number
n/a
Brand Name
Neoligaments TM
Version/Model Number
102-1080
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 2021
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
JDR
Product Code Name
Staple, Fixation, Bone
Public Device Record Key
7ccb9aff-c68a-4494-8adf-746bb0a46f13
Public Version Date
July 29, 2021
Public Version Number
7
DI Record Publish Date
October 09, 2015
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 38 |