Duns Number:796452311
Device Description: STR MAT-5X30X76-2T-STD FOAM-CAL117-PU
Catalog Number
23112
Brand Name
STR MAT-5X30X76-2T-STD FOAM-CAL117-PU
Version/Model Number
SM-53076-2T-SF117-PU
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 16, 2020
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
FPP
Product Code Name
Stretcher, Hand-Carried
Public Device Record Key
0cb8e0fe-c2bc-4291-944a-2d68e5be248e
Public Version Date
September 17, 2020
Public Version Number
2
DI Record Publish Date
April 06, 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 | 478 |
2 | A medical device with a moderate to high risk that requires special controls. | 8062 |