Duns Number:005473608
Device Description: COE SPRAY™ II Gallon Refill (3.8L)
Catalog Number
557128
Brand Name
COE SPRAY™ II
Version/Model Number
557128
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2018
Issuing Agency
In HIBCC
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
LRJ
Product Code Name
Disinfectant, medical devices
Public Device Record Key
8ece1b79-34a7-4f69-b3d3-8ab1600173de
Public Version Date
May 02, 2018
Public Version Number
3
DI Record Publish Date
February 10, 2017
Package DI Number
D6585571282
Quantity per Package
4
Contains DI Package
D6585571281
Package Discontinue Date
May 18, 2017
Package Status
Not in Commercial Distribution
Package Type
-
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 |