Duns Number:440211428
Device Description: Breast localization needle mod. SINUREP 20G X 100 mm
Catalog Number
-
Brand Name
SINUREP
Version/Model Number
SR20100-02
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
-
Product Code
MIJ
Product Code Name
Needle, Tumor Localization
Public Device Record Key
a938c249-3e19-4265-838f-06b0f3daa618
Public Version Date
June 26, 2018
Public Version Number
1
DI Record Publish Date
May 26, 2018
Package DI Number
18056515888175
Quantity per Package
10
Contains DI Package
08056515888178
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 |