Duns Number:283174985
Device Description: Precision Reamer
Catalog Number
1229
Brand Name
CEKA & PRECI-LINE ATTACHMENTS
Version/Model Number
1229
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
-
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
DZA
Product Code Name
DRILL, DENTAL, INTRAORAL
Public Device Record Key
3aaf697c-ad0f-4a84-b557-cf42e49325bf
Public Version Date
April 21, 2021
Public Version Number
2
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 |