Duns Number:806806220
Device Description: Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vagina Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled with Pull Tab, Extra-Long, *Vital Care Industries Custom Label*
Catalog Number
-
Brand Name
Sheathes
Version/Model Number
26801VCI
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
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
40e5ed2e-fd9a-4373-8a62-443ce13f8896
Public Version Date
May 23, 2018
Public Version Number
3
DI Record Publish Date
November 16, 2017
Package DI Number
20842418102174
Quantity per Package
6
Contains DI Package
10842418102177
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 |