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