Catalog Number

72204398

Brand Name

BIOSURE

Version/Model Number

72204398

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K142948

Product Code

MAI

Product Code Name

Fastener, fixation, biodegradable, soft tissue

Public Device Record Key

dc651e57-8631-4370-b2b7-d7d5f0d6cd5c

Public Version Date

November 03, 2020

Public Version Number

6

DI Record Publish Date

August 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-