Diamond Wire - Single Needle Diamond Wire - Innovative Med

Duns Number:928308407

Device Description: Single Needle Diamond Wire

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More Product Details

Catalog Number

-

Brand Name

Diamond Wire

Version/Model Number

IM-DW

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

GDI

Product Code Name

Dissector, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

622f0595-e55a-4a74-94cb-56d2eb0e9e71

Public Version Date

July 27, 2018

Public Version Number

1

DI Record Publish Date

June 26, 2018

Additional Identifiers

Package DI Number

10851314007226

Quantity per Package

2

Contains DI Package

00851314007229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INNOVATIVE MED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 13