Catalog Number

-

Brand Name

OSTEOTOME, CURVED, 8MM

Version/Model Number

95-8008C

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

-

Product Code

EMM

Product Code Name

Chisel, Osteotome, Surgical

Public Device Record Key

a0cb814b-ed91-480a-b5dc-29947f03a7b0

Public Version Date

June 13, 2019

Public Version Number

1

DI Record Publish Date

June 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-