Apollo - Apollo Reusable Surgical Punch, 4.5mm - Maruho Medical, Inc.

Duns Number:117630237

Device Description: Apollo Reusable Surgical Punch, 4.5mm

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More Product Details

Catalog Number

-

Brand Name

Apollo

Version/Model Number

01-45P

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

-

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 Details

Product Code

LRY

Product Code Name

Punch, Surgical

Device Record Status

Public Device Record Key

2969ecff-d885-4198-a914-a359c20cf63b

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

August 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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