Duns Number:806806220
Device Description: Seamless Viral Barrier Adhesive End, Polyurethane, 1" x 3" Face to 4.5"W x 12"L, Non-Steri Seamless Viral Barrier Adhesive End, Polyurethane, 1" x 3" Face to 4.5"W x 12"L, Non-Sterile, Specialty Ultrasound Probe Cover, Rolled
Catalog Number
-
Brand Name
Sheathes3D
Version/Model Number
ADH-50001-1245
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
ade37668-f292-4af9-93a0-c2d8577f437e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 29, 2018
Package DI Number
20842418102457
Quantity per Package
3
Contains DI Package
10842418102450
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 |