LightBeam - 50 pieces of Lighted Small Tri-Loop Curette - EAR TECHNOLOGY CORPORATION

Duns Number:023930584

Device Description: 50 pieces of Lighted Small Tri-Loop Curette

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More Product Details

Catalog Number

-

Brand Name

LightBeam

Version/Model Number

LB04-Refill

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

Yes

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

JYG

Product Code Name

Curette, Ear

Device Record Status

Public Device Record Key

eead94a7-d94a-4dfb-86fd-7d95ff828f93

Public Version Date

May 17, 2022

Public Version Number

1

DI Record Publish Date

May 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EAR TECHNOLOGY CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 1