Duns Number:283174985
Device Description: CEKA SOL FILIGRAN
Catalog Number
CS00 F
Brand Name
CEKA & PRECI-LINE ATTACHMENTS
Version/Model Number
CS00 F
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
EJS
Product Code Name
ALLOY, OTHER NOBLE METAL
Public Device Record Key
6e1085f8-5c56-40fd-95f8-fc0010feb336
Public Version Date
April 07, 2021
Public Version Number
1
DI Record Publish Date
March 30, 2021
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 | 346 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |