Duns Number:079375431
Device Description: HALYARD* EchoLong 21? Bevel - 18 GA x 150 mm - Stimulating
Catalog Number
ELL18150SGC
Brand Name
Halyard
Version/Model Number
39235
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
47c87ed6-a4f5-4b4f-963b-607f267dff15
Public Version Date
November 23, 2020
Public Version Number
5
DI Record Publish Date
March 15, 2017
Package DI Number
30680651392351
Quantity per Package
10
Contains DI Package
10680651392357
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 | 269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |