Duns Number:107260002
Device Description: T 80153 Foam with Acrylic Probe Cover, Blue and Pink Mix, Heart (1 1/4")
Catalog Number
T 80153
Brand Name
Tarry Temperature Probe Cover
Version/Model Number
T 80153
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
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
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
ce26ccf5-0db7-48a4-8c49-b83991f6e7cc
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 28, 2020
Package DI Number
20810031980417
Quantity per Package
10
Contains DI Package
10810031980410
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |