Duns Number:005473608
Device Description: GC SPRAY-CIDE™ One Gallon Refill (3.8L)
Catalog Number
555128
Brand Name
GC SPRAY-CIDE™
Version/Model Number
555128
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 14, 2021
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
1f76c160-3668-4b94-b076-cc88ab8474bf
Public Version Date
September 15, 2021
Public Version Number
3
DI Record Publish Date
February 10, 2017
Package DI Number
D6585551282
Quantity per Package
4
Contains DI Package
D6585551281
Package Discontinue Date
July 28, 2020
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 |