Duns Number:806806220
Device Description: Latex, 1.25"D x 8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Straig Latex, 1.25"D x 8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Straight, Rolled, Individually Wrapped
Catalog Number
-
Brand Name
Sheathes
Version/Model Number
10080
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K925869,K925869,K925869
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
095ace5a-3715-426d-b8f5-c713919b0d34
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
20842418100040
Quantity per Package
12
Contains DI Package
10842418100043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |