Beacon - 8MP Integrated Dual-screen Display - Shenzhen Beacon Display Technology Co.,Itd.

Duns Number:526873362

Device Description: 8MP Integrated Dual-screen Display

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More Product Details

Catalog Number

-

Brand Name

Beacon

Version/Model Number

C82W+

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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

K202374

Product Code Details

Product Code

PGY

Product Code Name

Display, Diagnostic Radiology

Device Record Status

Public Device Record Key

a5dcab7d-e349-4583-983e-e81066de77cd

Public Version Date

December 10, 2020

Public Version Number

1

DI Record Publish Date

December 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHENZHEN BEACON DISPLAY TECHNOLOGY CO.,ITD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20