Infinity Internal Hex System - UCLA Ø3.5mm 4.5MM WIDE NON HEX FOR INFINITY - ACE SURGICAL SUPPLY CO., INC.

Duns Number:042763706

Device Description: UCLA Ø3.5mm 4.5MM WIDE NON HEX FOR INFINITY INTERNAL HEX

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More Product Details

Catalog Number

2093545

Brand Name

Infinity Internal Hex System

Version/Model Number

2093545

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

K102981

Product Code Details

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Record Status

Public Device Record Key

d5f6427e-1a8f-4e39-a60d-21fa421da214

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACE SURGICAL SUPPLY CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1288
2 A medical device with a moderate to high risk that requires special controls. 943
U Unclassified 6