Duns Number:738288096
Catalog Number
-
Brand Name
PHX VA Instrument Set
Version/Model Number
79-1000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PZG
Product Code Name
Surgical Eye Tray
Public Device Record Key
00db1719-3954-4a4f-83f3-5bdd4e8d5241
Public Version Date
August 05, 2022
Public Version Number
1
DI Record Publish Date
July 28, 2022
Package DI Number
05060745555710
Quantity per Package
8
Contains DI Package
05060745555703
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 | 12 |