Duns Number:965417181
Device Description: Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion E3-10, BK Medical 881 Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion E3-10, BK Medical 8819 & E10C4, Carestream E10C4 & E14C4, Hitachi Aloka Medical UST-679, Philips BP10-5ec (Affiniti 50, Affiniti 70, HD11, HD115 & HD7XE systems) & C9-4ec (HD7 XE w/3.0.1, software and above & HD9 systems) and Samsung Medison NEV4-9ES & NER4-9ES Ultrasound Transducers
Catalog Number
5252
Brand Name
Sterile Disposable Endocavity Needle Guide Kit
Version/Model Number
5252
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
K970891,K971115,K971722,K970891,K971115,K971722
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
4762c553-5268-433f-bfd6-5b9903e1c900
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
May 24, 2019
Package DI Number
10841912106070
Quantity per Package
24
Contains DI Package
00841912106073
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 |