Duns Number:008312423
Device Description: SMITH&NEPHEW 1502 W/220V INDIA/S.AFRICA
Catalog Number
SM1502BCORD7
Brand Name
Thermasplint
Version/Model Number
SM-1502B-CORD7
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
IRQ
Product Code Name
Unit, Heating, Powered
Public Device Record Key
26cf43af-eb31-4f24-ae81-fd2694918ddf
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 11, 2019
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 | 157 |
2 | A medical device with a moderate to high risk that requires special controls. | 296 |