Duns Number:106712748
Catalog Number
-
Brand Name
EchoGlo
Version/Model Number
24-4101-24
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171968,K171968,K171968
Product Code
BSP
Product Code Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Public Device Record Key
8f5a16f5-12ad-43de-8526-f82ef62ce2ab
Public Version Date
August 17, 2018
Public Version Number
3
DI Record Publish Date
March 19, 2018
Package DI Number
35019517065965
Quantity per Package
25
Contains DI Package
15019517065961
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 686 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 1 |