Duns Number:447228586
Device Description: DISPOSABLE REPOSITIONABLE NEEDLE 20G x 50 mm FOR MAMMARY NODULE LOCALIZATION, SINGLE HOOK
Catalog Number
PR2005
Brand Name
RepoMark
Version/Model Number
PR2005
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
-
Product Code
GDF
Product Code Name
Guide, Needle, Surgical
Public Device Record Key
b61af620-5334-4dcb-bbc7-1dd9058a7099
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 17, 2021
Package DI Number
18056138586359
Quantity per Package
10
Contains DI Package
08056138586352
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 | 228 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 138 |