Pomee - Extracting Forceps #203 universal lower bicuspid - POMEE CORPORATION

Duns Number:645717646

Device Description: Extracting Forceps #203 universal lower bicuspid incisor root

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More Product Details

Catalog Number

706-203

Brand Name

Pomee

Version/Model Number

706-203

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

-

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

EMH

Product Code Name

Forceps, Rongeur, Surgical

Device Record Status

Public Device Record Key

4a374252-7b62-46d0-ab4c-bc0853fcb766

Public Version Date

December 16, 2021

Public Version Number

1

DI Record Publish Date

December 08, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POMEE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 616