Duns Number:118021111
Device Description: M&S Technologies Smart System® Standard
Catalog Number
-
Brand Name
M&S Technologies Smart System® Standard
Version/Model Number
Smart System Standard
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HOS
Product Code Name
Projector, Ophthalmic
Public Device Record Key
c3652316-e327-456c-9a07-3f870764f5cd
Public Version Date
September 19, 2022
Public Version Number
2
DI Record Publish Date
July 06, 2022
Package DI Number
00850040295085
Quantity per Package
1
Contains DI Package
00850040295559
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SS-STD
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |