Duns Number:023055619
Device Description: Easy-Tag Pre-Printed, Broken, Red 250/Spl
Catalog Number
1001-928
Brand Name
SCANLAN® Easy-Tag™ Tracking System
Version/Model Number
1001-928
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
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
315b0fe4-4dfa-4019-9a2a-cc3076b9de54
Public Version Date
November 04, 2021
Public Version Number
2
DI Record Publish Date
May 18, 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 | 1949 |
2 | A medical device with a moderate to high risk that requires special controls. | 855 |