Duns Number:134614411
Device Description: Sterile PercuNav™ tracking bracket and endocavity needle guide with (2.6 x 20cm) and (3.5 Sterile PercuNav™ tracking bracket and endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Philips C10-4ec transducers
Catalog Number
667-147
Brand Name
Tracking Bracket Kit
Version/Model Number
667-147
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092619,K092619
Product Code
IYO
Product Code Name
System, imaging, pulsed echo, ultrasonic
Public Device Record Key
539b6341-76f4-42ad-98db-bbd428c032c6
Public Version Date
September 06, 2021
Public Version Number
6
DI Record Publish Date
August 22, 2017
Package DI Number
00841436106894
Quantity per Package
24
Contains DI Package
10841436106891
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 443 |