Catalog Number

OBE1519CH9F

Brand Name

BIOPSYBELL

Version/Model Number

OSTEOBELL EXPLANT

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"

Yes

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

K130616

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

25659749-3b9b-47e5-966f-33f270e0eb53

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

June 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-