Duns Number:079840876
Device Description: Trial, 39mm x 27mm x 20mm, 25 deg
Catalog Number
RA2-122025
Brand Name
Meridian
Version/Model Number
RA2-122025
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HWT
Product Code Name
TEMPLATE
Public Device Record Key
5f0b573a-9215-4efc-99a9-18ad3eb35c59
Public Version Date
January 07, 2021
Public Version Number
1
DI Record Publish Date
December 30, 2020
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 | 5602 |
2 | A medical device with a moderate to high risk that requires special controls. | 14020 |
U | Unclassified | 21 |