Duns Number:051957769
Device Description: RELION DIGITAL PROBE COVERS ORAL 30/PER PACK 24/CASE
Catalog Number
144-621-000
Brand Name
RELION
Version/Model Number
144-621-000
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
-
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
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
fe0bbe9e-6f76-4ed6-89d2-ee5af51ee26a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 17, 2016
Package DI Number
30681306915215
Quantity per Package
6
Contains DI Package
00681131060264
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |