Duns Number:806806220
Device Description: Seamless Viral Barrier, Polyurethane, 1.18"D x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Seamless Viral Barrier, Polyurethane, 1.18"D x 11.8"L, Non-Sterile, Pre-Gelled Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled with Pull Tab, Extra-Long, Individually Wrapped
Catalog Number
-
Brand Name
Sheathes3D Pre-Gelled
Version/Model Number
77380RP
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
-
Product Code
OIP
Product Code Name
Radiology-Diagnostic Kit
Public Device Record Key
1ddd8e9b-784f-4112-8cee-be2f9d52cb6d
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 25, 2019
Package DI Number
20842418104147
Quantity per Package
6
Contains DI Package
10842418104140
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 |