Duns Number:080798558
Device Description: Hydraulic Stretcher, two tone color Blue and Gray base. Stretcher includes O2 tank, IV Pol Hydraulic Stretcher, two tone color Blue and Gray base. Stretcher includes O2 tank, IV Pole,
Catalog Number
-
Brand Name
Setmark Incorporated
Version/Model Number
TR-102
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
b1c8a153-4f81-4f1a-bc03-7a4580c0f7d4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 31, 2018
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |