Duns Number:880141023
Device Description: Deleey Centerline Posterior With Linear Metal
Catalog Number
23007
Brand Name
Deleey Centerline Posterior With Linear Metal
Version/Model Number
23007
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"
-
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
ELM
Product Code Name
Denture, Plastic, Teeth
Public Device Record Key
51887942-5d15-4b72-ba07-df95b314eb68
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 01, 2017
Package DI Number
17701126550034
Quantity per Package
20
Contains DI Package
07701126550037
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 94 |