N/A - Reusable Obturator, 7.5mm x 90mm - Maruho Medical, Inc.

Duns Number:117630237

Device Description: Reusable Obturator, 7.5mm x 90mm

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

09-37590

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

NBH

Product Code Name

Accessories, Arthroscopic

Device Record Status

Public Device Record Key

e22f677f-56d5-4cf3-aa0b-af65b98e0391

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 28, 2021

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