Duns Number:623191194
Device Description: Tec-Cide Plus Glutaraldehyde 3%, Gallon
Catalog Number
500-0001
Brand Name
Tec-Cide Plus
Version/Model Number
500-0001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
13a4565d-6a4a-44e4-90a2-9f147f546890
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 26, 2017
Package DI Number
20862632000315
Quantity per Package
4
Contains DI Package
10862632000318
Package Discontinue Date
-
Package Status
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 | 464 |
2 | A medical device with a moderate to high risk that requires special controls. | 78 |