Duns Number:627572217
Device Description: CUSTOMED I-MAX ASPIRATION TIP BIOPSY NEEDLE, 16G X 50MM, WHITE
Catalog Number
9002501650
Brand Name
CUSTOMED
Version/Model Number
712057831650
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K092338,K092338
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
135c8005-688e-4584-a72e-e8ebb491b40a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
M20890025016501
Quantity per Package
10
Contains DI Package
M20890025016500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10/BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |