Duns Number:806806220
Device Description: Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elas Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled, Extra-Long
Catalog Number
-
Brand Name
Sheathes
Version/Model Number
26340
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
9883f802-267b-4552-b58e-1bd7a2b5e61a
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
20842418100446
Quantity per Package
3
Contains DI Package
10842418100449
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 |