Zuga - Titanium Abutment, 4.3mm, 7.0mm height x 1.5mm - ZUGA MEDICAL, INC.

Duns Number:055605664

Device Description: Titanium Abutment, 4.3mm, 7.0mm height x 1.5mm gum height

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More Product Details

Catalog Number

-

Brand Name

Zuga

Version/Model Number

TAA-430-170

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

K122664

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

8ab1c301-5d59-45f7-b298-06653f3e3646

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

January 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZUGA MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 153