Duns Number:107260002
Device Description: T 97700 Reusable Use Skin Temperature Probe
Catalog Number
T 97700
Brand Name
Tarry Probes
Version/Model Number
T 97700
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071977
Product Code
FMT
Product Code Name
Warmer, Infant Radiant
Public Device Record Key
f6bf4464-704d-44a8-93bd-d2f28bbb8d7a
Public Version Date
September 25, 2018
Public Version Number
4
DI Record Publish Date
September 20, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |