Duns Number:058614483
Device Description: Fine Needle Biopsy Needle
Catalog Number
-
Brand Name
SharkCore
Version/Model Number
C-22-05
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"
Yes
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
K141894,K141894
Product Code
FCG
Product Code Name
Biopsy needle
Public Device Record Key
e6a289e0-c850-4a1e-b018-f86d7216b578
Public Version Date
June 30, 2022
Public Version Number
6
DI Record Publish Date
September 08, 2017
Package DI Number
10855208005107
Quantity per Package
5
Contains DI Package
00855208005100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |