Duns Number:130785884
Device Description: Disposable Probe Cover Accessories
Catalog Number
-
Brand Name
Ultrasound Probe Cover Biopsy Needle Guide Kit
Version/Model Number
28-EG135LF
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"
Yes
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
K011265,K011265
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
feb3142d-9829-4f28-ad39-16c5ea57de41
Public Version Date
July 14, 2022
Public Version Number
1
DI Record Publish Date
July 06, 2022
Package DI Number
10848340018357
Quantity per Package
10
Contains DI Package
00848340018350
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 619 |
U | Unclassified | 3 |