AtoN Classic Headlight with 7' Fiber Optic Cable - Light, Surgical, Endoscopic, Accessory - LONG ISLAND TECH

Duns Number:030256600

Device Description: Light, Surgical, Endoscopic, Accessory

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More Product Details

Catalog Number

-

Brand Name

AtoN Classic Headlight with 7' Fiber Optic Cable

Version/Model Number

P003260

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

FSW

Product Code Name

Light, Surgical, Endoscopic

Device Record Status

Public Device Record Key

a9131bae-eb51-44d9-b1c6-d6f1a9a3ec1c

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LONG ISLAND TECH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 10