Duns Number:740491188
Device Description: S14 Surgismart Container
Catalog Number
-
Brand Name
Daniels
Version/Model Number
1001110523
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 03, 2019
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
K001337
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
228a858b-645a-4f8c-98e9-95ba9fb1ddff
Public Version Date
October 10, 2019
Public Version Number
4
DI Record Publish Date
May 02, 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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |