POM PLUNGER N.0 Yellow - 16 POM plungers Yellow diam. 0.90 - Produits dentaires S.A.

Duns Number:480420090

Device Description: 16 POM plungers Yellow diam. 0.90

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More Product Details

Catalog Number

-

Brand Name

POM PLUNGER N.0 Yellow

Version/Model Number

20200

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)

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

EKI

Product Code Name

Carrier, Amalgam, Operative

Device Record Status

Public Device Record Key

c89cba0a-fd55-45e8-befe-a09ef020e16a

Public Version Date

June 29, 2022

Public Version Number

1

DI Record Publish Date

June 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRODUITS DENTAIRES S.A." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 278
2 A medical device with a moderate to high risk that requires special controls. 1