Duns Number:054875224
Device Description: Universal IC Attachment
Catalog Number
1200112
Brand Name
Universal IC Attachment
Version/Model Number
1200112
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 28, 2022
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
EHO
Product Code Name
BAR, PREFORMED
Public Device Record Key
99c4ed59-c487-4ab9-b1f9-ed6e9dd3125b
Public Version Date
October 31, 2022
Public Version Number
3
DI Record Publish Date
June 28, 2022
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 | 958 |
2 | A medical device with a moderate to high risk that requires special controls. | 1846 |