Flexi-Post - Flexi-Post Intro Kit Size 0-1-2 Titanium - ESSENTIAL DENTAL SYSTEMS, INC.

Duns Number:101147171

Device Description: Flexi-Post Intro Kit Size 0-1-2 Titanium

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More Product Details

Catalog Number

115-00

Brand Name

Flexi-Post

Version/Model Number

115-00

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)

Yes

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

ELR

Product Code Name

POST, ROOT CANAL

Device Record Status

Public Device Record Key

8f036017-6681-4392-b8b2-afefde1adef2

Public Version Date

July 20, 2020

Public Version Number

1

DI Record Publish Date

July 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ESSENTIAL DENTAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 249
2 A medical device with a moderate to high risk that requires special controls. 26
U Unclassified 3