Pomee - Ladmore Plastic Filling Instrument #3 - POMEE CORPORATION

Duns Number:645717646

Device Description: Ladmore Plastic Filling Instrument #3

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More Product Details

Catalog Number

708-003

Brand Name

Pomee

Version/Model Number

708-003

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

EIY

Product Code Name

Instrument, Filling, Plastic, Dental

Device Record Status

Public Device Record Key

0554b2b1-5aac-481d-8b48-b25737ccbc1e

Public Version Date

January 12, 2022

Public Version Number

1

DI Record Publish Date

January 04, 2022

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