Duns Number:079375431
Device Description: MIC-KEY* Threaded Extension Set, SECUR-LOK* Right Angle Connector and Clamp
Catalog Number
0126-12
Brand Name
Halyard
Version/Model Number
94943
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
K982894,K982894
Product Code
KNT
Product Code Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Public Device Record Key
e1d5f3e9-556c-4913-94f0-72d8957698ac
Public Version Date
April 20, 2020
Public Version Number
6
DI Record Publish Date
March 09, 2017
Package DI Number
30680651949432
Quantity per Package
5
Contains DI Package
20680651949435
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cs
| 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 |