Catalog Number

800-0274

Brand Name

Biomet® Biologics

Version/Model Number

800-0274

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

K091722

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

e0667c93-0c25-462e-b123-aff77b69167b

Public Version Date

June 19, 2019

Public Version Number

1

DI Record Publish Date

June 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-