Etchmaster - EtchMaster® disposable Small microetching tip - GROMAN INC.

Duns Number:020124663

Device Description: EtchMaster® disposable Small microetching tip prefilled with 50 micron Glass Beads (Color EtchMaster® disposable Small microetching tip prefilled with 50 micron Glass Beads (Color code marking PURPLE) with Regular bend nozzle.

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More Product Details

Catalog Number

EM-S-P-RB

Brand Name

Etchmaster

Version/Model Number

EM-S-P-RB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 29, 2026

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"

Yes

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

K030292,K030292,K030292,K030292,K030292

Product Code Details

Product Code

KOJ

Product Code Name

Airbrush

Device Record Status

Public Device Record Key

1f191d37-fdf6-49f8-bbe2-79ec82576ae3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

40817494020067

Quantity per Package

100

Contains DI Package

00817494020069

Package Discontinue Date

August 29, 2026

Package Status

In Commercial Distribution

Package Type

Box