HEINE mini 3000® LED F.O. Diagnostic Set - Heine Optotechnik GmbH & Co. KG

Duns Number:315274563

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More Product Details

Catalog Number

D-886.11.021

Brand Name

HEINE mini 3000® LED F.O. Diagnostic Set

Version/Model Number

S

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

5658c265-d45d-4c67-8b97-57ea0f976a06

Public Version Date

May 10, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEINE OPTOTECHNIK GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 179