Rospital Productos Medicos - HYPODERMIC SAFETY NEEDLE WITH 3CC SYRINGE LUER - ATLAS MEDICAL PRODUCTS LLC

Duns Number:013112308

Device Description: HYPODERMIC SAFETY NEEDLE WITH 3CC SYRINGE LUER LOCK 21G X 1 1/2, EA.

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More Product Details

Catalog Number

SYFTY3215

Brand Name

Rospital Productos Medicos

Version/Model Number

SYFTY3215

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

K190183,K190183,K190183

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

4ff804c8-26ff-41a5-892e-0e02b0d057b2

Public Version Date

July 14, 2020

Public Version Number

1

DI Record Publish Date

July 06, 2020

Additional Identifiers

Package DI Number

10812460027124

Quantity per Package

100

Contains DI Package

00812460027127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER BOX

"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