Duns Number:134614411
Device Description: Sterile (3.2 tapered to 1.9 x 32cm) latex cover
Catalog Number
610-985
Brand Name
Transducer Cover
Version/Model Number
610-985
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
K970515,K970515
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
ccb0a083-63b8-4c5e-8c5e-f3f965ffc65d
Public Version Date
March 22, 2022
Public Version Number
6
DI Record Publish Date
August 22, 2017
Package DI Number
00841436104685
Quantity per Package
24
Contains DI Package
10841436104682
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |