Duns Number:283174985
Device Description: CEKA M3 IR
Catalog Number
OL 334
Brand Name
CEKA & PRECI-LINE ATTACHMENTS
Version/Model Number
OL 334
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
EGG
Product Code Name
ATTACHMENT, PRECISION, ALL
Public Device Record Key
723a1d10-cd20-4a72-afe4-310ed5eb6fe4
Public Version Date
April 28, 2021
Public Version Number
1
DI Record Publish Date
April 20, 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 |