ForceBraid™ - Maruho Medical, Inc.

Duns Number:117630237

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More Product Details

Catalog Number

-

Brand Name

ForceBraid™

Version/Model Number

01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

K150438,K150438

Product Code Details

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Device Record Status

Public Device Record Key

d4d92122-86cb-4491-8173-3fea01c59072

Public Version Date

February 25, 2021

Public Version Number

6

DI Record Publish Date

March 14, 2016

Additional Identifiers

Package DI Number

B048VAL2024WT1

Quantity per Package

6

Contains DI Package

B048VAL2024WT0

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