Duns Number:544571975
Device Description: Disposable Needle Guides for use with GE E8C, E8C-RS, E8CS, E8CS-RC, E8CS-RS, E8CS-SC, IC Disposable Needle Guides for use with GE E8C, E8C-RS, E8CS, E8CS-RC, E8CS-RS, E8CS-SC, IC5-9H, E72, E721, MTZ, MZ; ECM E610P; Samsung VR5-9 Ultrasound Transducers
Catalog Number
DE-002
Brand Name
InnoFine
Version/Model Number
DE-002
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
-
Product Code
OIJ
Product Code Name
Biopsy Needle Guide Kit
Public Device Record Key
e1cd13ee-47f6-4de3-9e2d-9a826f77cc38
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
April 27, 2020
Package DI Number
16971554725026
Quantity per Package
24
Contains DI Package
06971554725029
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. | 101 |