Duns Number:060783407
Device Description: PiroVue Gastroc Recession System Sterile Kit, Retractor 25mm Ht., Blade 2.7 mm, 5 Count
Catalog Number
-
Brand Name
PiroVue Gastroc Recession System, 5 Count
Version/Model Number
PV-2527-05
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"
Yes
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
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
243a4112-16ad-4ca0-b38f-9bdec1d9152f
Public Version Date
September 23, 2022
Public Version Number
5
DI Record Publish Date
June 12, 2017
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 152 |
2 | A medical device with a moderate to high risk that requires special controls. | 560 |