F-Splint-Aid & Slim Introkit - Polydentia SA

Duns Number:481461598

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More Product Details

Catalog Number

-

Brand Name

F-Splint-Aid & Slim Introkit

Version/Model Number

5980

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K962374

Product Code Details

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Device Record Status

Public Device Record Key

51f0dee7-6393-408a-9957-1b64ffca41ed

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 28, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POLYDENTIA SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 229
2 A medical device with a moderate to high risk that requires special controls. 13