Duns Number:631734758
Device Description: Morrison Steerable Needle 21G 17cm. Percutaneous injection and aspiration procedures and t Morrison Steerable Needle 21G 17cm. Percutaneous injection and aspiration procedures and tissue sampling in liver,kidney, muscle and subcutaneous tissue.
Catalog Number
13550
Brand Name
Morrison Steerable Needle
Version/Model Number
13550
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K150625,K150625,K150625
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
b11e47c7-6a39-4be9-96ca-010fe03fac88
Public Version Date
July 12, 2019
Public Version Number
5
DI Record Publish Date
September 05, 2016
Package DI Number
27350031355509
Quantity per Package
18
Contains DI Package
17350031355502
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Transportation box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |