Duns Number:081840873
Device Description: APPLICATOR 10CM ASSY
Catalog Number
-
Brand Name
CHATTANOOGA
Version/Model Number
78046
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
IMI
Product Code Name
Ultrasonic diathermy for use in applying therapeutic deep heat
Public Device Record Key
7c31a492-a123-418b-a6b6-23ad3ecb2b2e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2016
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 |