Duns Number:078470558
Catalog Number
8002-062-222
Brand Name
T/Pad
Version/Model Number
8002-062-222
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
ILO
Product Code Name
Pack, hot or cold, water circulating
Public Device Record Key
fb1b1e5b-1b32-4894-a16c-f1366d4beef9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
57613327261429
Quantity per Package
10
Contains DI Package
07613327261424
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |