MedSource Triangle Bandage - Triangular Bandage (non-woven) - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: Triangular Bandage (non-woven)

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More Product Details

Catalog Number

Not Applicable

Brand Name

MedSource Triangle Bandage

Version/Model Number

MS-11050

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)

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

ILI

Product Code Name

Sling, Arm

Device Record Status

Public Device Record Key

d2c85bbd-1713-42d8-9d85-6db62ff44d2b

Public Version Date

May 05, 2021

Public Version Number

1

DI Record Publish Date

April 27, 2021

Additional Identifiers

Package DI Number

00816703024485

Quantity per Package

240

Contains DI Package

00816703024478

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90