IH Temporary Abutment - SEWON MEDIX IH Temporary Abutment Regular Hex - sewon medix Inc.

Duns Number:688731065

Device Description: SEWON MEDIX IH Temporary Abutment Regular Hex Non-Coating Set Product, Ø4.5x1.0mm

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

AIHTARH4510

Brand Name

IH Temporary Abutment

Version/Model Number

AIHTARH4510

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

K153521

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

dfbed347-673d-4572-9ecf-3115921092f3

Public Version Date

September 18, 2019

Public Version Number

1

DI Record Publish Date

September 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEWON MEDIX INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 185