Duns Number:134614411
Device Description: Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use wi Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with ALPINION E3-10, BK Medical 8819, Hitachi Aloka Medical UST-679, Philips Bp10-5ec, C9-4ec and Samsung Medison NEV4-9ES, NER4-9ES transducers
Catalog Number
610-959, 610-959-5
Brand Name
Needle Guide
Version/Model Number
610-959, 610-959-5
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
K970514,K970514,K970514
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
7057221b-8286-4d50-98a2-e14cc03b2502
Public Version Date
June 17, 2022
Public Version Number
8
DI Record Publish Date
August 22, 2017
Package DI Number
00841436104623
Quantity per Package
24
Contains DI Package
10841436104620
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 |