IH Multi-unit CCM Cylinder - SEWON MEDIX IH Multi-unit CCM Cylinder Bridge Set - sewon medix Inc.

Duns Number:688731065

Device Description: SEWON MEDIX IH Multi-unit CCM Cylinder Bridge Set Product, Ø4.8x4.5x12.0x9.65mm

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More Product Details

Catalog Number

AMCC100H

Brand Name

IH Multi-unit CCM Cylinder

Version/Model Number

AMCC100H

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)

-

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

7ce5e8e5-a41a-4e7e-aea9-155d632f7dc6

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

November 22, 2018

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