Duns Number:041674552
Device Description: Shears, EMS , White, 7.5"
Catalog Number
Not Applicable
Brand Name
MedSource Shears
Version/Model Number
MS-SH009W
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
JOK
Product Code Name
Scissors, Medical, Disposable
Public Device Record Key
bcef3461-c652-4f9d-ae98-49c601ed210c
Public Version Date
August 19, 2021
Public Version Number
1
DI Record Publish Date
August 11, 2021
Package DI Number
00816703028001
Quantity per Package
4
Contains DI Package
00816703027998
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |