Duns Number:317409001
Device Description: Sawblade sterile for Synthes®, Zimmer® UPS90 x 22 x 1,19 mm
Catalog Number
EZ2212.M50.
Brand Name
EZ Blade
Version/Model Number
EZ2212.M50.YJ
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
-
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
GFA
Product Code Name
Blade, Saw, General & Plastic Surgery, Surgical
Public Device Record Key
7ef0c7e5-8718-4717-b48a-439ba48f3472
Public Version Date
September 05, 2022
Public Version Number
1
DI Record Publish Date
August 26, 2022
Package DI Number
24053613284961
Quantity per Package
1
Contains DI Package
14053613284964
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 154 |
2 | A medical device with a moderate to high risk that requires special controls. | 70 |