Magicore GPS Drill Tube - InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Duns Number:631169224

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More Product Details

Catalog Number

-

Brand Name

Magicore GPS Drill Tube

Version/Model Number

MGDT5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

d6472ef9-e0eb-4f77-9cc7-281be678ca63

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

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