Duns Number:008301772
Device Description: 7500-N stretcher with standard chassis and litter frame only. Includes IS6 6th wheel stee 7500-N stretcher with standard chassis and litter frame only. Includes IS6 6th wheel steering, 02 holder, Trendelenburg levle lock, dual SS side rails.
Catalog Number
7500-N-Diacor
Brand Name
Pedigo Products, Inc.
Version/Model Number
7500-N-Diacor
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
f05050d6-8010-4806-8071-9a0e655b6258
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 |