Catalog Number

-

Brand Name

apollo

Version/Model Number

00-45T

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

HWX

Product Code Name

Tap, Bone

Public Device Record Key

96dd0645-6cf2-49b5-9c0f-da5e16ba6c60

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

February 28, 2021

Package DI Number

10818614021949

Quantity per Package

5

Contains DI Package

00818614021942

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box