American Eagle Instruments - MOPPER SUPER PLUGGER MED-LG TN - AMERICAN EAGLE INSTRUMENTS, INC.

Duns Number:790776850

Device Description: MOPPER SUPER PLUGGER MED-LG TN

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More Product Details

Catalog Number

AEC/PMSPMLTN

Brand Name

American Eagle Instruments

Version/Model Number

AEC/PMSPMLTN

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

EKR

Product Code Name

PLUGGER, ROOT CANAL, ENDODONTIC

Device Record Status

Public Device Record Key

c2c5307d-6c11-4075-a580-a4472fb82bd1

Public Version Date

October 05, 2022

Public Version Number

4

DI Record Publish Date

May 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN EAGLE INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1253
2 A medical device with a moderate to high risk that requires special controls. 4