MANI MEDIUM H-FILES - MANI H-FILES - MANI, INC.

Duns Number:690622428

Device Description: MANI H-FILES

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More Product Details

Catalog Number

-

Brand Name

MANI MEDIUM H-FILES

Version/Model Number

25MM #37

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

-

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

EKS

Product Code Name

FILE, PULP CANAL, ENDODONTIC

Device Record Status

Public Device Record Key

193c1321-2c4a-4388-93e6-890faa3472db

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MANI, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1000
2 A medical device with a moderate to high risk that requires special controls. 88