Catalog Number

P822365228

Brand Name

BIOSORB

Version/Model Number

OTIS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 09, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K071155

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

b80bd925-9947-4655-96b0-8a84be3362ac

Public Version Date

September 26, 2022

Public Version Number

5

DI Record Publish Date

October 13, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-