Lexicon - Finger Plugger Pl 25B 25MM - TULSA DENTAL PRODUCTS LLC

Duns Number:942778564

Device Description: Finger Plugger Pl 25B 25MM

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More Product Details

Catalog Number

FP25B25

Brand Name

Lexicon

Version/Model Number

FP25B25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

3ce41a07-4d21-403e-9dd6-40cfce7ad019

Public Version Date

September 08, 2022

Public Version Number

1

DI Record Publish Date

August 31, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TULSA DENTAL PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1973
2 A medical device with a moderate to high risk that requires special controls. 35
U Unclassified 16