Duns Number:806806220
Device Description: Seamless Viral Barrier, Latex-Free, 1.18"D x 8"L, Sterile, Ultrasound Probe Cover with 3" Seamless Viral Barrier, Latex-Free, 1.18"D x 8"L, Sterile, Ultrasound Probe Cover with 3" Debris Shield, Vaginal/Rectal, Tapered, Bi-Directionally Rolled
Catalog Number
-
Brand Name
Sheathes3D
Version/Model Number
75440
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
b047d85a-fa20-40a4-9df9-cb95d93742bd
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
February 28, 2018
Package DI Number
20842418102303
Quantity per Package
6
Contains DI Package
10842418102306
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 |