Catalog Number

OSTMPU27

Brand Name

HU-FRIEDY

Version/Model Number

OSTMPU27

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GFI

Product Code Name

OSTEOTOME, MANUAL

Public Device Record Key

72031c40-7279-47d0-9800-a82c6021a0c1

Public Version Date

August 24, 2020

Public Version Number

1

DI Record Publish Date

August 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-