Duns Number:351991547
Device Description: 20G (0.9mm) 35 cm needle with 0.40x10 mm marker
Catalog Number
0078
Brand Name
Gold Anchor
Version/Model Number
2035-10-B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K201117,K201117
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
b80e1700-1e23-492c-98d9-ca83c2371d0e
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
December 15, 2020
Package DI Number
07340145700797
Quantity per Package
10
Contains DI Package
07340145700780
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 36 |