Duns Number:107260002
Device Description: T 80152 Foam with Acrylic Probe Cover, Gold, Heart (1 1/4")
Catalog Number
T 80152
Brand Name
Tarry Temperature Probe Cover
Version/Model Number
T 80152
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
b789dfeb-e0ce-40c4-85cb-0730b49f2792
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 28, 2020
Package DI Number
30810031980407
Quantity per Package
10
Contains DI Package
20810031980400
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 |