Duns Number:603420183
Device Description: SEW EASY® CASSETTE SINGLES, 3.5MM
Catalog Number
022160
Brand Name
SEW EASY® CASSETTE
Version/Model Number
022160
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
Yes
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
DWS
Product Code Name
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Public Device Record Key
c6447a43-3b34-4721-b9e7-c0598afcf557
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
March 13, 2020
Package DI Number
10850200006732
Quantity per Package
12
Contains DI Package
00850200006735
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 56 |
2 | A medical device with a moderate to high risk that requires special controls. | 31 |