Duns Number:806806220
Device Description: Polyurethane, 1"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal Polyurethane, 1"D x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Semi-Rolled on Paper-Back, Extra-Long
Catalog Number
-
Brand Name
Sheathes
Version/Model Number
20340
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
K990175,K990175,K990175
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
61829ddf-1e7c-4f65-9dfc-7057aaf76b08
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
20842418100293
Quantity per Package
3
Contains DI Package
10842418100296
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 |