Duns Number:035237962
Device Description: ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S5.0 mm resorbable plug, 6. ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driverQty. 6
Catalog Number
-
Brand Name
ZipE® Knotless Tissue Repair and Attachment Devices
Version/Model Number
RA6-6550-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
K162429
Product Code
MAI
Product Code Name
Fastener, Fixation, Biodegradable, Soft Tissue
Public Device Record Key
da0cebd2-ba9d-4571-9b58-381408767be4
Public Version Date
June 12, 2019
Public Version Number
1
DI Record Publish Date
June 04, 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. | 8 |