Adult Myelography Tray - Adult Myelography Tray - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Adult Myelography Tray

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More Product Details

Catalog Number

A4324AWSP

Brand Name

Adult Myelography Tray

Version/Model Number

A4324AWSP

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"

Yes

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

OGJ

Product Code Name

Nerve Block Tray

Device Record Status

Public Device Record Key

0e0c86ed-0f78-42ba-8f38-ec30566e26c3

Public Version Date

June 22, 2021

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

20886333220643

Quantity per Package

10

Contains DI Package

00886333220649

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