Duns Number:440211428
Device Description: Soft tissue biopsy needle mod. U.DUO, 14G x 160 mm
Catalog Number
-
Brand Name
UNIVERSAL DUO
Version/Model Number
UD14160-0P
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"
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
K092338,K092338
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
32a14a41-b4ec-47c6-bf05-9ccf27fa1101
Public Version Date
November 29, 2018
Public Version Number
1
DI Record Publish Date
October 29, 2018
Package DI Number
18055002909683
Quantity per Package
10
Contains DI Package
08055002909686
Package Discontinue Date
-
Package Status
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 436 |