Catalog Number

B-2905P

Brand Name

BisBlock 3ml bottle in Bag

Version/Model Number

B-2905P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 2019

Issuing Agency

In HIBCC

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

EJK

Product Code Name

LINER, CAVITY, CALCIUM HYDROXIDE

Public Device Record Key

9fd000f2-b3fa-4924-97bc-bd713976bddb

Public Version Date

March 06, 2019

Public Version Number

4

DI Record Publish Date

June 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-