Catalog Number

-

Brand Name

APOLLO

Version/Model Number

MSA-5515

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

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

9de74532-f07c-43a3-b32d-2da4efaf76e3

Public Version Date

February 25, 2021

Public Version Number

6

DI Record Publish Date

August 17, 2017

Package DI Number

10818614020126

Quantity per Package

5

Contains DI Package

00818614020129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX