Duns Number:081840873
Device Description: HYDROCOLLATOR, E-1, W/O, STD PACKS
Catalog Number
-
Brand Name
CHATTANOOGA
Version/Model Number
2102-1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IRQ
Product Code Name
UNIT, HEATING, POWERED
Public Device Record Key
faef1b60-4399-4aac-a036-d57631c31a9c
Public Version Date
April 07, 2022
Public Version Number
1
DI Record Publish Date
March 30, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 784 |
2 | A medical device with a moderate to high risk that requires special controls. | 1030 |
3 | A medical device with high risk that requires premarket approval | 8 |