JEDMED - ILLUMINATOR LED MACRO VIEW - JEDMED INSTRUMENT COMPANY

Duns Number:092987189

Device Description: ILLUMINATOR LED MACRO VIEW

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More Product Details

Catalog Number

39-7451

Brand Name

JEDMED

Version/Model Number

39-7451

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

ERA

Product Code Name

Otoscope

Device Record Status

Public Device Record Key

6724a994-3eaa-4610-b92e-5eed65afc97c

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JEDMED INSTRUMENT COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 871
2 A medical device with a moderate to high risk that requires special controls. 127
U Unclassified 11