Inrad - SelectCore Coaxial with Hiliter 13 ga x 15 cm - Inrad

Duns Number:940023385

Device Description: SelectCore Coaxial with Hiliter 13 ga x 15 cm

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More Product Details

Catalog Number

-

Brand Name

Inrad

Version/Model Number

691514

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

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Device Record Status

Public Device Record Key

c2f8a29e-526c-4506-85af-74e9b70b59da

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

December 01, 2016

Additional Identifiers

Package DI Number

10817295020975

Quantity per Package

10

Contains DI Package

00817295020978

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"INRAD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 53