Duns Number:014464314
Device Description: General Purpose Sterile Probe Cover, 6” x 96” with Sterile Gel and Bands
Catalog Number
111460
Brand Name
Cone Instruments
Version/Model Number
111460
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
K211969,K211969
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
291cc192-9577-4679-942a-66300af62760
Public Version Date
October 08, 2021
Public Version Number
1
DI Record Publish Date
September 30, 2021
Package DI Number
00850033380385
Quantity per Package
24
Contains DI Package
00850033380378
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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. | 489 |