Pediatric Lumbar Puncture Tray - Pediatric Lumbar Puncture Tray with 22ga x 3.8cm - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Pediatric Lumbar Puncture Tray with 22ga x 3.8cm Spinal Needle Drug Free

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More Product Details

Catalog Number

A4302CDF

Brand Name

Pediatric Lumbar Puncture Tray

Version/Model Number

A4302CDF

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

291df301-515b-40ce-96c3-1b7167a07254

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

20886333220490

Quantity per Package

10

Contains DI Package

00886333220496

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