Catalog Number

905046

Brand Name

9-10MM MODULAR BIO-CORE DILATOR

Version/Model Number

905046

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

-

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

HTZ

Product Code Name

INSTRUMENT, CUTTING, ORTHOPEDIC

Public Device Record Key

8715d6ed-cabc-4572-ad26-0ffd6feb2e1a

Public Version Date

June 19, 2019

Public Version Number

1

DI Record Publish Date

June 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-