Duns Number:806806220
Device Description: Isoprene, 1.18"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Isoprene, 1.18"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long
Catalog Number
-
Brand Name
SheathesISO
Version/Model Number
70303
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
df923eb9-4ae5-4d9d-9f59-94ca0d4b24d5
Public Version Date
May 23, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
20842418100774
Quantity per Package
6
Contains DI Package
10842418100777
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 |