Duns Number:806806220
Device Description: Polyurethane, 1.18"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamle Polyurethane, 1.18"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Straight, Narrow, Rolled, Extra-Long, Individually Wrapped
Catalog Number
-
Brand Name
Sheathes3D
Version/Model Number
75339VCI
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"
-
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
K153212,K153212,K153212
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
2de13145-001b-4882-bdad-67280a916ac2
Public Version Date
September 14, 2018
Public Version Number
1
DI Record Publish Date
August 14, 2018
Package DI Number
20842418104062
Quantity per Package
6
Contains DI Package
10842418104065
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 |