Arterial Needle - Winged Arterial Needle 18ga x 2.75" (7cm) - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Winged Arterial Needle 18ga x 2.75" (7cm)

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More Product Details

Catalog Number

195352

Brand Name

Arterial Needle

Version/Model Number

195352

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

GDF

Product Code Name

Guide, Needle, Surgical

Device Record Status

Public Device Record Key

e2767ffa-8e51-457f-82e6-dcb7b7c33188

Public Version Date

July 06, 2022

Public Version Number

1

DI Record Publish Date

June 28, 2022

Additional Identifiers

Package DI Number

10886333208514

Quantity per Package

10

Contains DI Package

00886333208517

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205