gSource - Shapleigh Ear Curette 6" str large - GSOURCE LLC

Duns Number:008162518

Device Description: Shapleigh Ear Curette 6" str large

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More Product Details

Catalog Number

gS 26.0482

Brand Name

gSource

Version/Model Number

gS 26.0482

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

JYG

Product Code Name

Curette, Ear

Device Record Status

Public Device Record Key

8b3887f6-1392-4525-9443-d7893cb01019

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

January 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GSOURCE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4617
2 A medical device with a moderate to high risk that requires special controls. 280