Duns Number:035237962
Device Description: ZipE® Knotless Tissue Repair and Attachment Devices5.0 mm titanium screw, 6.5 resorbable c ZipE® Knotless Tissue Repair and Attachment Devices5.0 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver
Catalog Number
-
Brand Name
ZipE® Knotless Tissue Repair and Attachment Devices
Version/Model Number
A6-6550-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
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
2c29605d-a028-424b-b766-c568e36fb192
Public Version Date
March 21, 2019
Public Version Number
3
DI Record Publish Date
September 20, 2018
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. | 8 |