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
70303VCI
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
0f2ed10f-b770-4aa5-8f2d-7780a2587275
Public Version Date
September 10, 2018
Public Version Number
1
DI Record Publish Date
August 08, 2018
Package DI Number
20842418103836
Quantity per Package
6
Contains DI Package
10842418103839
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 |