ML4 LED HEADLIGHT - ML4 LED HEADLIGHT WITH HEADBAND, MPACK UNPLUGGED - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: ML4 LED HEADLIGHT WITH HEADBAND, MPACK UNPLUGGED & TRANSFORMER

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More Product Details

Catalog Number

J-008.31.415

Brand Name

ML4 LED HEADLIGHT

Version/Model Number

J-008.31.415

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)

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

EQH

Product Code Name

SOURCE, CARRIER, FIBEROPTIC LIGHT

Device Record Status

Public Device Record Key

a9fd2413-b974-460d-8dbe-84e283c9fc06

Public Version Date

October 18, 2018

Public Version Number

1

DI Record Publish Date

September 17, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414