Duns Number:447228586
Device Description: 10 CS-DISPOSABLE NEEDLE 18G x114mmFOR SOFT TISSUE BIOPSYWITH MANUAL ACTION
Catalog Number
PM18114
Brand Name
HandCut
Version/Model Number
PM18114
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 14, 2021
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
MJG
Product Code Name
Device, Percutaneous, Biopsy
Public Device Record Key
0a328874-aa88-4c37-afd5-8d89cf3a6646
Public Version Date
May 27, 2021
Public Version Number
6
DI Record Publish Date
January 04, 2017
Package DI Number
08058341219195
Quantity per Package
10
Contains DI Package
08058341219188
Package Discontinue Date
May 14, 2021
Package Status
Not 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 | 228 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 138 |