Duns Number:151772415
Device Description: CALL CORD,DURACALL,SINGLE, UNIVERSAL, 1/4 PHONE JACK- 2 CONDUCTOR, COILED CABLE,WHITE, 16 CALL CORD,DURACALL,SINGLE, UNIVERSAL, 1/4 PHONE JACK- 2 CONDUCTOR, COILED CABLE,WHITE, 16 FEET
Catalog Number
-
Brand Name
CALL CORD,DURACALL,SGL,UNV,1/4-2C,COILED,WHT,16FT
Version/Model Number
9900CLXYY
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IQA
Product Code Name
System, Environmental Control, Powered
Public Device Record Key
030b5718-53a9-4fc2-9e17-36b5086eb059
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2017
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 792 |