Duns Number:928998905
Device Description: Probe Covers (TIDI) are a latex free barrier used for Geratherm mercury free oral or recta Probe Covers (TIDI) are a latex free barrier used for Geratherm mercury free oral or rectal thermometers. They are a single use disposable item.
Catalog Number
10030
Brand Name
Geratherm Thermometer Sheaths
Version/Model Number
Sheaths fits non mercury glass thermometers
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PEM
Product Code Name
Dental Barriers And Sleeves
Public Device Record Key
5d9028e9-9b81-43c4-a25c-b74db6337962
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
Package DI Number
10614801100301
Quantity per Package
100
Contains DI Package
00614801100304
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |