Apollo - Maruho Medical, Inc.

Duns Number:117630237

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More Product Details

Catalog Number

-

Brand Name

Apollo

Version/Model Number

LA-6520

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Device Record Status

Public Device Record Key

d703f83a-37c7-44d9-a1cf-26597bf3b05d

Public Version Date

February 25, 2021

Public Version Number

5

DI Record Publish Date

August 17, 2017

Additional Identifiers

Package DI Number

10818614020164

Quantity per Package

5

Contains DI Package

00818614020167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MARUHO MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 90
2 A medical device with a moderate to high risk that requires special controls. 162