Duns Number:002111896
Device Description: Thermal Probe Cover20/pouch, 10 pouches/case, 500 per case
Catalog Number
A10008
Brand Name
TenderTrode Plus™
Version/Model Number
A10008
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"
Yes
For Single-Use
Yes
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
K915831,K915831,K915831
Product Code
FMT
Product Code Name
Warmer, Infant Radiant
Public Device Record Key
c5051d7b-79a3-421a-9ab3-068d9d9306f5
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 02, 2018
Package DI Number
20813150020576
Quantity per Package
10
Contains DI Package
10813150020579
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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |