CCM UCLA Abutment (for BESTic) [OCT] - EBI Inc.

Duns Number:689515003

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More Product Details

Catalog Number

-

Brand Name

CCM UCLA Abutment (for BESTic) [OCT]

Version/Model Number

EBCUC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 13, 2016

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

-

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

41a4bf03-67db-4f03-a4dc-3484626af03f

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

March 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EBI INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 71