Duns Number:005473608
Device Description: COE® SPACER TRAYS #31D Upper R, Lower L Perforated-Partial
Catalog Number
250311
Brand Name
COE®
Version/Model Number
250311
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
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
EBH
Product Code Name
MATERIAL, IMPRESSION TRAY, RESIN
Public Device Record Key
20892540-a259-41da-970d-35bc8a4b4ad9
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 2022
Package DI Number
40386040012059
Quantity per Package
36
Contains DI Package
20386040012055
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |