Duns Number:447228586
Device Description: CS 10-DISPOSABLE NEEDLE 16Gx120mmFOR SOFT TISSUE BIOPSYCOMPATIBLE AUTOMATIC PROMAG® GUN
Catalog Number
MGP1612
Brand Name
FastCutP
Version/Model Number
MGP1612
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 13, 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
000e5a5c-f86c-4fa1-af59-4225e060096f
Public Version Date
May 27, 2021
Public Version Number
6
DI Record Publish Date
January 05, 2017
Package DI Number
08058341219201
Quantity per Package
10
Contains DI Package
08058341215166
Package Discontinue Date
May 13, 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 |