Implant Prosthetics - 3i Certain 3.4mm/4.1mm/5mm/6mm Titanium Screw - Implants and Attachments, Inc.

Duns Number:054875224

Device Description: 3i Certain 3.4mm/4.1mm/5mm/6mm Titanium Screw (10-Pack)

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More Product Details

Catalog Number

8001650-10

Brand Name

Implant Prosthetics

Version/Model Number

8001650-10

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"

Yes

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

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

c73f494c-32db-4421-b8fc-0fb9af80ceed

Public Version Date

October 19, 2022

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMPLANTS AND ATTACHMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 958
2 A medical device with a moderate to high risk that requires special controls. 1846