Magic UCLA Cement Retained Type - InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Duns Number:631169224

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More Product Details

Catalog Number

-

Brand Name

Magic UCLA Cement Retained Type

Version/Model Number

MPLP55BT

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

K173120

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

6678cf77-a458-41eb-a3de-0fcde15b1218

Public Version Date

December 29, 2020

Public Version Number

1

DI Record Publish Date

December 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOBIOSURG CO.,LTD(IBS IMPLANT CO.,LTD)" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 755
2 A medical device with a moderate to high risk that requires special controls. 1844