zumax - Ophthalmoscope LED Bulb,3.5V - Zumax Medical Co., LTD

Duns Number:421348837

Device Description: Ophthalmoscope LED Bulb,3.5V

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More Product Details

Catalog Number

-

Brand Name

zumax

Version/Model Number

P4900-LED

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

HLJ

Product Code Name

Ophthalmoscope, Battery-Powered

Device Record Status

Public Device Record Key

bde3e672-12ca-4481-8508-095bcf444f05

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

August 27, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZUMAX MEDICAL CO., LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 16