Duns Number:023055619
Device Description: SURG-I-BAND® Color Coding - Data Matrix - Censitrac - Assorted Lengths, Orange
Catalog Number
1001-1114
Brand Name
Scanlan® SURG-I-BAND® Color Coding - Data Matrix
Version/Model Number
1001-1114
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"
Yes
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
3797196f-d514-49fc-b6f4-f310c6e9d0de
Public Version Date
August 17, 2018
Public Version Number
1
DI Record Publish Date
July 17, 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 |