Duns Number:008301772
Device Description: 7500-NE: Eye Stretcher, narrow. With hydraulic height adjustment, pneumatic adjustable Fow 7500-NE: Eye Stretcher, narrow. With hydraulic height adjustment, pneumatic adjustable Fowler, Recovery Knee Gatch, Quick-Release
Catalog Number
7500-NE
Brand Name
Pedigo Products, Inc.
Version/Model Number
7500-NE
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPO
Product Code Name
Stretcher, Wheeled
Public Device Record Key
b6cffbd7-2a11-40a0-a386-c0043f64a04f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
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. | 22 |