Duns Number:058614483
Device Description: Meniscal Stapler Up Curved Loading Unit
Catalog Number
160511
Brand Name
Polysorb
Version/Model Number
160511
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 2019
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
K013890,K013890
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
05277e0d-e971-435c-b2db-ac99de09a6dc
Public Version Date
September 09, 2022
Public Version Number
6
DI Record Publish Date
August 28, 2015
Package DI Number
10884521176836
Quantity per Package
5
Contains DI Package
20884521176833
Package Discontinue Date
October 02, 2019
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |