Duns Number:965417181
Device Description: Sterile Disposable Endocavity Needle Guide for use with Philips -ATL C9-5, C9-5ec & C9-5IC Sterile Disposable Endocavity Needle Guide for use with Philips -ATL C9-5, C9-5ec & C9-5ICT Ultrasound Transducers
Catalog Number
5390
Brand Name
Sterile Disposable Endocavity Needle Guide
Version/Model Number
5390
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K971115,K971722,K971115,K971722
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
86322b74-2b1c-4bc2-9f0a-8a7f4c0b0581
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
March 13, 2020
Package DI Number
10841912106308
Quantity per Package
24
Contains DI Package
00841912106301
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 451 |