Catalog Number

72204414

Brand Name

BIOSURE

Version/Model Number

72204414

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

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

07530987-11bc-44e5-9a05-dae5b56627c8

Public Version Date

November 03, 2020

Public Version Number

6

DI Record Publish Date

September 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-