Catalog Number

-

Brand Name

HS II Fixture Mini RBM Pre-Mounted

Version/Model Number

AHS2M3515R28

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K080387

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

bfc2a8c7-a22e-45ef-94c0-475769e8cfc5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 08, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-