Duns Number:806806220
Device Description: Latex-Free, 3.5"W x 48"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Ela Latex-Free, 3.5"W x 48"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled
Catalog Number
-
Brand Name
Sheathes
Version/Model Number
50040-4835
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
956a9ff0-9b95-491d-a775-bd070f22369a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 07, 2018
Package DI Number
20842418102426
Quantity per Package
3
Contains DI Package
10842418102429
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 |