Duns Number:963886457
Device Description: Stretcher, Wheeled, Powered, 675lb Max
Catalog Number
MC675CL
Brand Name
TransMotionMedical
Version/Model Number
S675
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
K110671
Product Code
INK
Product Code Name
Stretcher, Wheeled, Powered
Public Device Record Key
1bf6f75c-283c-4238-8eee-780d12a1027f
Public Version Date
May 13, 2020
Public Version Number
1
DI Record Publish Date
May 05, 2020
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 | 83 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |