SIMPLY ICONIC™ Implant - 5.2mmD x 13mmL, 3.4mmD Platform - IMPLANT DIRECT SYBRON MANUFACTURING LLC

Duns Number:868856969

Device Description: 5.2mmD x 13mmL, 3.4mmD Platform

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More Product Details

Catalog Number

675213RP

Brand Name

SIMPLY ICONIC™ Implant

Version/Model Number

675213RP

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

Yes

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

K201553

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

1585de22-5d22-489a-af35-29834922f392

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

April 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMPLANT DIRECT SYBRON MANUFACTURING LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 1817
U Unclassified 6