Duns Number:065673912
Catalog Number
WC100
Brand Name
Worley™ Slitter
Version/Model Number
00884450269510
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)
-
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
184ee60a-3441-4cd6-b41b-f4bfd729751e
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
July 19, 2019
Package DI Number
10884450269517
Quantity per Package
5
Contains DI Package
00884450269510
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 188 |