UR-4MD - UR-4MD VIDEO REC BSC HOSP - Dongguan Teac Electronics Co., Ltd.

Duns Number:544883143

Device Description: UR-4MD VIDEO REC BSC HOSP

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More Product Details

Catalog Number

-

Brand Name

UR-4MD

Version/Model Number

1921062092

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LMB

Product Code Name

Device, Digital Image Storage, Radiological

Device Record Status

Public Device Record Key

5126d57a-8ecb-4b33-9faa-0c385c8a9eee

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DONGGUAN TEAC ELECTRONICS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7