Rospital Productos Medicos - HYPODERMIC NEEDLES, STERILE, BLISTER, LUER LOCK, - ATLAS MEDICAL PRODUCTS LLC

Duns Number:013112308

Device Description: HYPODERMIC NEEDLES, STERILE, BLISTER, LUER LOCK, 23G X 1 1/2 ", EA.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

SUDN0235

Brand Name

Rospital Productos Medicos

Version/Model Number

SUDN0235

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

8b078f02-1416-4913-bec8-c8c8db132b4c

Public Version Date

June 12, 2020

Public Version Number

1

DI Record Publish Date

June 04, 2020

Additional Identifiers

Package DI Number

10812460027360

Quantity per Package

100

Contains DI Package

00812460027363

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER

"ATLAS MEDICAL PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 7