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

Duns Number:020124663

Device Description: EtchMaster® disposable Small microetching tip prefilled with 30 micron Glycine (Color code EtchMaster® disposable Small microetching tip prefilled with 30 micron Glycine (Color code marking ORANGE) with Regular bend nozzle.

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More Product Details

Catalog Number

EM-S-O-RB

Brand Name

Etchmaster

Version/Model Number

EM-S-O-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,K030292

Product Code Details

Product Code

KOJ

Product Code Name

Airbrush

Device Record Status

Public Device Record Key

7c13fb0a-f5e1-4f11-aa89-eb9bf3090f15

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

50817494020163

Quantity per Package

32

Contains DI Package

20817494020162

Package Discontinue Date

August 29, 2026

Package Status

In Commercial Distribution

Package Type

Box