Duns Number:134614411
Device Description: Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5) and (14 × 91 Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare eM6C-G2 transducers
Catalog Number
H48701MP
Brand Name
GE Ultra-Pro II Starter Kit
Version/Model Number
H48701MP
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
-
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
K093713,K093713
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
54dfa50d-f3d9-45c3-b232-588b1333a33b
Public Version Date
June 10, 2022
Public Version Number
10
DI Record Publish Date
August 22, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |